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4 jobs found for Regulatory Affairs

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    • permanent
    • full-time
    about the companyA medical devices company with presence globally. about the jobyou will be preparing and submitting regulatory applications to authorities in the ASEAN region. You will be required to maintain and renew regulatory licenses in the ASEAN region in a timely manner. Besides, to develop regulatory strategies and project timelines for new product registrations or change submissions based on input from key cross-functions. about the manager/teamThis role will be an individual contributor and reports into RA Manager. skills and experience requiredYou must be equipped with at least a Degree in Lifesciences, Engineering or equivalent and have at least 1 year of RA experiences in the medical industry. . To apply online please use the 'apply' function. (EA: 94C3609/ R22107967) Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
    about the companyA medical devices company with presence globally. about the jobyou will be preparing and submitting regulatory applications to authorities in the ASEAN region. You will be required to maintain and renew regulatory licenses in the ASEAN region in a timely manner. Besides, to develop regulatory strategies and project timelines for new product registrations or change submissions based on input from key cross-functions. about the manager/teamThis role will be an individual contributor and reports into RA Manager. skills and experience requiredYou must be equipped with at least a Degree in Lifesciences, Engineering or equivalent and have at least 1 year of RA experiences in the medical industry. . To apply online please use the 'apply' function. (EA: 94C3609/ R22107967) Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
    • permanent
    • full-time
    about the role. The healthcare industry has an essential responsibility of improving the quality of our lives. You’ll be working directly with a Manager and/or Senior Consultant to build specialisations in key functional areas such as research & development, regulatory affairs, diagnostics, biotechnology and medical devices! You’ll have the responsibility and autonomy to provide a full-suite of talent recruitment services to some of the most prestigious and innovative healthcare companies in Singapore. As an associate recruitment consultant with the life sciences team, you’ll be: Growing the candidate pool through effective sourcing & screening of high-calibre talent who meet clients’ skills specifications and job requirementsUsing tech-lite resources like networking, social selling, index management and HR tech tools to build and manage your candidate and client databaseAnalysing and clarifying employers’ hiring requirements and providing consult and recruitment solutions to address any talent concerns or challenges. about the manager/ team As an Associate Recruitment Consultant, you’ll receive direct support and guidance from a dynamic life sciences team of five (and growing) experienced recruitment specialists to help you become a successful 360 recruitment consultant. Together with our recruitment consultants, the marketing and HR specialists as well as client solutions account directors are here to support your account and candidate management, as well as accelerate your personal career development roadmap in your first year. skills and experienceDegree in LifeSciences/Biomedical/Chemistry/BiotechnologySelf-motivated individual who are goals- or resulted- oriented Passionate interest in the healthcare industry Has a lifelong learning attitude and curious about the elements impacting the local labour market Exceptional at creating opportunities and influencing outcomesCommercially- and digitally-savvyExcited to build a meaningful career in the recruitment industryTo apply, email your resume to francine.wong(@)randstad.com.sg. Only shortlisted candidates will be contacted. (EA: 94C3609/​R22104071)Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.Our benefits & rewards programme: https://www.randstad.com.sg/join-our-team/benefits-and-rewards/Our career development roadmap: https://www.randstad.com.sg/join-our-team/career-growth/
    about the role. The healthcare industry has an essential responsibility of improving the quality of our lives. You’ll be working directly with a Manager and/or Senior Consultant to build specialisations in key functional areas such as research & development, regulatory affairs, diagnostics, biotechnology and medical devices! You’ll have the responsibility and autonomy to provide a full-suite of talent recruitment services to some of the most prestigious and innovative healthcare companies in Singapore. As an associate recruitment consultant with the life sciences team, you’ll be: Growing the candidate pool through effective sourcing & screening of high-calibre talent who meet clients’ skills specifications and job requirementsUsing tech-lite resources like networking, social selling, index management and HR tech tools to build and manage your candidate and client databaseAnalysing and clarifying employers’ hiring requirements and providing consult and recruitment solutions to address any talent concerns or challenges. about the manager/ team As an Associate Recruitment Consultant, you’ll receive direct support and guidance from a dynamic life sciences team of five (and growing) experienced recruitment specialists to help you become a successful 360 recruitment consultant. Together with our recruitment consultants, the marketing and HR specialists as well as client solutions account directors are here to support your account and candidate management, as well as accelerate your personal career development roadmap in your first year. skills and experienceDegree in LifeSciences/Biomedical/Chemistry/BiotechnologySelf-motivated individual who are goals- or resulted- oriented Passionate interest in the healthcare industry Has a lifelong learning attitude and curious about the elements impacting the local labour market Exceptional at creating opportunities and influencing outcomesCommercially- and digitally-savvyExcited to build a meaningful career in the recruitment industryTo apply, email your resume to francine.wong(@)randstad.com.sg. Only shortlisted candidates will be contacted. (EA: 94C3609/​R22104071)Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.Our benefits & rewards programme: https://www.randstad.com.sg/join-our-team/benefits-and-rewards/Our career development roadmap: https://www.randstad.com.sg/join-our-team/career-growth/
    • permanent
    • S$5,000 - S$10,000, per month, + AWS + VB
    • full-time
    about the companyOur client is a global leader in providing certification, inspection, and test services for companies across sectors. With an extensive network across ASEAN, this company now has exciting opportunities for a driven Medical/MHS Auditor to join their dynamic team, to support the ASEAN region in performing Audits, inspections and trainings for clients.about the jobPerform Audits/Inspections in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standardsPerform in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)Conduct audits on clients’ medical device quality systems based on regulatory requirements for access into EU, Japan and CanadaAssist Sales by providing technical advice to clients and respond to enquiries Process clients’ queries, Change Notifications, EC certificate extensions and audits effectively Take charge of pre/post audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentations etc.Maintain authorizations for auditing and technical reviews and corresponding objective evidence Develop and review audit methodologies for accreditation complianceUndergo relevant training, qualification, or certification process to be qualified to provide further services. To generate, compile and prepare assessment reports and recommendations for review of certification bodies. job requirementDegree/diploma Minimum 5 years of relevant experience in the medical/pharmaceutical/biotechnology industry, with preferably at least 2 years in Quality Assurance work with manufacturers of medical devicesGood knowledge of medical device directives, ISO 9001 and ISO 13485 standards will be an added advantageGlobal Regulatory Affairs background, including MDD/IVDD is preferredMust be comfortable with extensive traveling (up to 50%) within ASEAN (largely Thailand and Malaysia, occasional travel to USA and Europe)If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.Please include your availability, expected salary and reason for leaving your current job.We regret that only shortlisted candidates will be contacted.Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.EA: 94C3609 / Reg: R21103172
    about the companyOur client is a global leader in providing certification, inspection, and test services for companies across sectors. With an extensive network across ASEAN, this company now has exciting opportunities for a driven Medical/MHS Auditor to join their dynamic team, to support the ASEAN region in performing Audits, inspections and trainings for clients.about the jobPerform Audits/Inspections in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standardsPerform in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)Conduct audits on clients’ medical device quality systems based on regulatory requirements for access into EU, Japan and CanadaAssist Sales by providing technical advice to clients and respond to enquiries Process clients’ queries, Change Notifications, EC certificate extensions and audits effectively Take charge of pre/post audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentations etc.Maintain authorizations for auditing and technical reviews and corresponding objective evidence Develop and review audit methodologies for accreditation complianceUndergo relevant training, qualification, or certification process to be qualified to provide further services. To generate, compile and prepare assessment reports and recommendations for review of certification bodies. job requirementDegree/diploma Minimum 5 years of relevant experience in the medical/pharmaceutical/biotechnology industry, with preferably at least 2 years in Quality Assurance work with manufacturers of medical devicesGood knowledge of medical device directives, ISO 9001 and ISO 13485 standards will be an added advantageGlobal Regulatory Affairs background, including MDD/IVDD is preferredMust be comfortable with extensive traveling (up to 50%) within ASEAN (largely Thailand and Malaysia, occasional travel to USA and Europe)If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.Please include your availability, expected salary and reason for leaving your current job.We regret that only shortlisted candidates will be contacted.Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.EA: 94C3609 / Reg: R21103172
    • permanent
    • S$5,500 - S$7,000, per month, + AWS + VB
    • full-time
    about the companyOur client is a leading manufacturer of innovative contact lenses and services, with main manufacturing sites in Singapore and other affiliates in other global markets. WIth a strong commitment to industry R&D, this company is now looking for a driven QA manager to lead their QA team.about the jobReporting into the Managing Director directly, you will:Ensure overall compliance adequacy and operational effectiveness of the QA Operations for the contact lens and lens care products manufacturing.Formulate and implement work procedures that meet quality and regulatory requirements.Ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirementsSupport the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.Work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield. Leading and participating in quality improvement programs and cross functional projects.Conduct failure analysis for customer complaint returns & manage customers’ complaint Coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.Develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, CE Certification, MOH Certification and other GMP systems.Update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides & ensure that gap analysis is performed Act as QMR and PRRC with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.job requirementDegree in Engineering, Life Sciences or equivalent.ISO 13485:2016 lead auditorMinimum 3 years of quality management related experience in the medical device/biotechnology/pharmaceutical industry with minimum 2 years experience in regulatory affairs.Familiar with cGMP and EU MDR 2017/745 requirements.Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.Knowledgeable in Validation/Qualification process..Proficient in Minitab and MS Office applications.If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.Please include your availability, expected salary and reason for leaving your current job.We regret that only shortlisted candidates will be contacted.Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.EA: 94C3609 / Reg: R21103172
    about the companyOur client is a leading manufacturer of innovative contact lenses and services, with main manufacturing sites in Singapore and other affiliates in other global markets. WIth a strong commitment to industry R&D, this company is now looking for a driven QA manager to lead their QA team.about the jobReporting into the Managing Director directly, you will:Ensure overall compliance adequacy and operational effectiveness of the QA Operations for the contact lens and lens care products manufacturing.Formulate and implement work procedures that meet quality and regulatory requirements.Ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirementsSupport the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.Work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield. Leading and participating in quality improvement programs and cross functional projects.Conduct failure analysis for customer complaint returns & manage customers’ complaint Coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.Develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, CE Certification, MOH Certification and other GMP systems.Update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides & ensure that gap analysis is performed Act as QMR and PRRC with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.job requirementDegree in Engineering, Life Sciences or equivalent.ISO 13485:2016 lead auditorMinimum 3 years of quality management related experience in the medical device/biotechnology/pharmaceutical industry with minimum 2 years experience in regulatory affairs.Familiar with cGMP and EU MDR 2017/745 requirements.Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.Knowledgeable in Validation/Qualification process..Proficient in Minitab and MS Office applications.If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.Please include your availability, expected salary and reason for leaving your current job.We regret that only shortlisted candidates will be contacted.Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.EA: 94C3609 / Reg: R21103172

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