Senior Manager of Regulatory Affairs

New

A Senior Regulatory Affairs Manager job is available in Bridgewater, NJ, courtesy of Adecco Medical & Science. This position is a long-term contract with a global pharmaceutical company. The pay rate is open.

JOB SUMMARY:

Plans and prepares complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. This role provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulations, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance.

RESPONSIBILITIES:

Plan and prepare complex regulatory documents for US and ROW product approvals
Manage post-approval projects. Approve manufacturing process changes as appropriate.
Plan and implement regulatory activities that support lifecycle management
Submits product labeling in compliance with legal/regulatory requirements
Participate in global teams and provides regulatory strategy and guidance to global product development teams
Develop US, Canada, and EU regulatory filing strategy. Provides regulatory strategy and guidance to global product owner/project team

Education and Experience:

BS degree in a scientific field, plus 8 years’ experience in regulatory affairs
MS degree in a scientific field, plus 6 years’ experience in regulatory affairs
PhD degree in a scientific field, plus 4 years’ experience in regulatory affairs
Class II medical device experience (REQUIRED)

If you are interested in this Senior Manager of Regulatory Affairs job, please APPLY NOW.
You can email your resume to majeda.hossain@adeccona.com or scott.shuman@adeccona.com

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled


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Reference number US_EN_2_106405_330651