Regulatory Affairs Specialist - Primary Talent Partners

Primary Talent Partners has a regulatory affairs specialist position available with our large life science client in Chaska, MN. This is a full-time W2 contract with an initial duration of 12 months and potential for extension and/or conversion.  
Responsibilities:

• The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs.
• Support the IA business units in meeting global registration requirements.
• As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.
• Ensures timely preparation of organized and scientifically valid reports both internally and externally.
• Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements.
• Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence.
• Prepares and maintains regulatory licenses, reports, and listings.

Minimum Qualifications:

• 3 years experience in diagnostic regulatory affairs, IVD/IVDR knowledge, and global registrations (EU, Canada, Brazil, Lating America, and/or Asia).
• Bachelors degree in sciences, engineering, or technical field and 5 years of relevant experience or a 
• Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields.
• Previous regulatory experience desirable. 
• Ability to prioritize assigned work.
• Ability to learn regulatory procedures.
• Ability to communicate accurately with internal and external contacts.
• Ability to work with team members to resolve problems and achieve goals.
• Experience with LEAN principles desirable.
• Experience with risk management (FMEA/HHA) desirable.
• RAC desired.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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