Remote: Regulatory Affairs Lead Consultant (231278)

Life Sciences & Technology | Regulatory Affairs

Job Description:

Our client is seeking a Regulatory Affairs Lead Consultant for a 10-month contract. The ideal candidate has a strong PMA Submissions background, as well as Site Transfer experience. This person will be working with multiple functions for a site transfer to Juarez, Mexico. They are looking to do a PMA submission around year-end timeframe. This consultant will help with the review of site transfer, talked about a 30 day submission in parallel of the 180 day submission so different set of reviewer for Tech Transfer vs. PMA. This person will need to write submission, interact with stakeholders (R&D, QA, MFG etc.) to obtain documentation needed to present PMA supplement. This person will be the lead in pushing the project along, however they will not be managing people.


Required Experience:

  • Skills: RA Lead, PMA Submissions Experience, Site Transfer experience.



Remote: Regulatory Affairs Lead Consultant (231278)



About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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