Regulatory Affairs Specialist

The Fountain Group; Chaska (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company, The Fountain Group, seeks a Regulatory Affairs specialist to manage regulatory initiatives for their Immunoassay team. The position requires strong expertise in the medical device sector and regulatory frameworks, supporting strategic compliance while fostering global regulatory consensus. This is a 16-month contract based in Chaska, MN, with potential for extension.

Qualifications

• 5+ years experience with Bachelor's, 3+ years with Master's, or 0-2 years with Doctorate.
• Demonstrated experience leading design change teams for Regulatory Affairs.
• Knowledge of regulations governing in-vitro diagnostics.

Responsibilities

• Manage IVDR Technical Files in compliance.
• Advise on current and emerging regulatory issues.
• Ensure sound post-market regulatory strategies.

Skills

Subject matter expertise in registration and commercialization of medical devices

Strong FDA, Health Canada, and EU submission experience

Education

Bachelor's Degree in Life Sciences

Master’s Degree in Life Sciences

Doctorate in Life Sciences

Job description

Details for the positionare as follows:

• 16 month contract to start with the possibility of extension or conversion depending on performance and budget.
• Rate: $45-50 an hour
• Location: Chaska, MN – 100% onsite
• M-F 8:00-5:00

Job Description:
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 products.

• 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.

Required Skills:

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

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