Senior Regulatory Affairs Specialist

Primary Talent Partners; Chaska (MN); On-site; USD 100,000 - 125,000; Full time

Job summary

A prominent biomedical manufacturing company is seeking a Senior Regulatory Affairs Specialist for an 18-month contract in Chaska, MN. The successful candidate will develop regulatory strategies and manage compliance initiatives, requiring a Bachelor's with significant experience in Life Sciences. This position offers a competitive hourly rate and opportunities for extensions or conversion.

Qualifications

• 5+ years experience in Life Sciences or 3+ years for Master's degree.
• Subject matter expertise in registration and commercialization of medical devices.
• Demonstrated experience leading design change teams for RA.

Responsibilities

• Create and execute regulatory strategies for pre-market and post-market activities.
• Manage IVDR Technical Files in compliance.
• Advise business teams on current or emerging regulatory issues.

Skills

Regulatory Affairs

Design Changes

IVDR or EMDR Experience

FDA Submission

Health Canada Submission

EU Submission

Education

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences

Doctorate in Life Sciences

RAC Certification

Job description

3 days ago Be among the first 25 applicants

Primary Talent Partners provided pay range

This range is provided by Primary Talent Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $50.00/hr

Primary Talent Partners has an 18-month contract opening for a Senior Regulatory Affairs Specialist to join a biomedical manufacturing company for an onsite position operating out of Chaska, MN.

Pay: $45/hr - $50/hr
Contract: 18 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Location:Chaska, MN
Schedule: M-F 8:00-5:00


Job Description:
The Senior Specialist Regulatory Affairs is an individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre-market and post-market activities. Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations. Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.

This position is in the Immunoassay Regulatory Affairs team and reports to the Manager of Regulatory Affairs. This role is responsible for managing regulatory initiatives, and working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. This position will lead and support change to legal manufacturer designation for Beckman products.

If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on.

In this role, you will have the opportunity to:

• Manage IVDR Technical Files in compliance
• Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
• Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

The essential requirements of the job include

• Bachelor's Degree with 5+ years of experience in Life Sciences or a Master's Degree with 3+ Years of experience in Life Sciences or Doctorate with 0-2 years of experience in Life Sciences
• Subject matter expertise in registration and commercialization of medical devices
• Demonstrated experience leading design change teams for RA.

Top 3 must haves

Experience with design changes

Demonstrated RA leadership on high visibility core team

IVDR or EMDR experience

Nice-to-have skills:

• Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
• RAC certificate
• Strong FDA, Health Canada, and EU submission experience

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 [e-mail]

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Seniority level

• Seniority level

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Employment type

• Employment type

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