Manager of Global Regulatory Affairs
Sterling Life Sciences - Los Angeles, CA

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Partial Job Description
1) Develop a global product regulatory strategy for surgical devices
2) Obtain and maintain all US and EU approvals
3) Develop and maintain EU Technical Files and ROW master files
4) Liaise with global regulatory counterparts to ensure regional requirements incorporated into product strategy development
5) Develop a product regulatory timeline aligned to company?s product development with key regulatory milestone and activities for agency filing
6) Coordinate with the team on the development of product labels
7) Ensure that labeling content and product documentation is developed in accordance with regulatory requirements
8) Participate as a member of the Product Development teams to build awareness of regulatory authority requirements and timing for submissions
9) Coordinate with RA global expansion team to ensure timely and accurate submissions to regulatory authorities
10) Act as a regulatory contact for assigned country regulatory authorities for surgical devices
11) Manage interactions with other company functions (e.g. Quality, Compliance) during regulatory authority inspections
12) Provide regulatory guidance/input to surgical device change control and internal product review boards

Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in Regulatory Affairs

CareerBuilder - 2 years ago - save job