regulatory affairs professional - 1 year contract in Singapore

posted
contact
jonathan ong, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0132361_1554890129
contact
jonathan ong, randstad
apply now

job description

about the company
Based in the region, this highly respected multinational organization continue to take the market by storm and are looking for a Regulatory Affairs professional to fulfill a 1 year contract. As a business, despite unfavourable conditions, they have still seen significant YOY growth and revenue thus providing a new range of leading related products and services to separate them from the chasing pack.

about the job



  • Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.

  • Write and file appropriate pre-market submission to US FDA; Write and maintain technical file / design dossier for CE marking a Class I, IIa and III medical devices; Write and maintain submission to Health Canada for device licensing.

  • Prepare CSTD submission package to Singapore Health Science Authority. Maintain the dealer licenses and product licenses/clearance for importation and sales

  • Support the international regulatory specialist within the global regulatory affairs department with product registration in accordance with their local regulatory requirements.

  • Maintain current knowledge and stay abreast with the Federal USA polices/guidance, Canadian regulations, EU medical device regulation and Singapore HSA regulation pertaining to legal distribution of medical products.

  • Implements and drives any new medical device requirement within the quality system environment.

  • Communicate the Medical Device Reporting and Vigilance Reporting in accordance with the local authorities’ regulatory requirement. Collaborate with the corporate office to conduct any local field safety corrective actions or product recalls.

  • Leads and/or works within department and/or cross functional teams in achieving regulatory affairs initiatives to support departmental goals in alignment to Plant's vision, objectives and shared values


about the manager/team
Reporting to the Regulatory Affairs Manager in a commercial function, you will be a team member responsible for current regulatory requirements and strategies for the company's design control projects. You will also be working with all levels of cross-functional associates and cross-site regulatory counterparts



skills and experience required





  • Diploma in Science related fields or or similar studies with at least 1 year relevant experience in regulatory affairs

  • Good team player, meticulous and resourceful

  • Able to work independently and has able to work in matrix environments

  • Industry knowledge or proven working experience in MNC settings would be a plus

  • Strong communication and interpersonal skills

  • Passionate in regulatory affairs

  • Meticulous, able to interpret complex data, flexible and adaptable to tight deadlines

  • Strong critical thinking coupled with sound decision making skills in bringing successful resolution to high-impact, complex, and/or cross-functional problems





To apply online please use the 'apply' function, alternatively you may contact us at 65171622 for a constructive discussion. Do note that only shortlisted candidates will be notified.

(EA: 94C3609/ R1551260)



skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Associate Degree/Diploma