Regulatory Affairs Specialist

Compunnel Inc.; Chaska (MN); On-site; USD 56,000 - 77,000; Full time

Job summary

Compunnel Inc. is seeking a Senior Specialist in Regulatory Affairs to lead regulatory strategies for medical device products across their lifecycles. The candidate will oversee compliance with IVDR/EMDR regulations and collaborate with project teams to ensure timely submissions and adherence to global standards.

Qualifications

• 5+ years of regulatory affairs experience for Bachelor's or 3+ years for Master's.
• Proven experience managing design changes in a regulated environment.
• Strong understanding of global medical device regulations.

Responsibilities

• Lead regulatory evaluations and submissions for design changes.
• Develop and implement post-market regulatory strategies.
• Manage IVDR-compliant Technical Files for immunoassay products.

Skills

Regulatory leadership

Design changes

IVDR compliance

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Doctorate (PhD, PharmD)

Job description

3 days ago Be among the first 25 applicants

Direct message the job poster from Compunnel Inc.

The Senior Specialist – Regulatory Affairs serves as a key subject-matter expert responsible for the development and execution of regulatory strategies across both pre-market and post-market product lifecycles. This role is heavily focused on managing post-market regulatory activities, including design change evaluations, IVDR/EMDR compliance, and new product development support. The successful candidate will demonstrate regulatory leadership within high-visibility project teams and collaborate with cross-functional stakeholders to ensure compliance and timely submissions.

Key Responsibilities:

• Lead regulatory evaluations and submissions related to design changes, ensuring alignment with global regulatory requirements (FDA, IVDR, EMDR, Health Canada, etc.).
• Provide regulatory leadership on high-impact core project teams and serve as the primary RA contact.
• Manage and maintain IVDR-compliant Technical Files for immunoassay products.
• Support change initiatives related to legal manufacturer designation for Beckman products.
• Develop and implement sound post-market product regulatory strategies that minimize the risk of delayed approvals or adverse findings.
• Partner with global regulatory colleagues and third-party stakeholders to ensure consistent practices and risk posture alignment.
• Track emerging global regulatory trends and assess potential business impact.

Must-Have Qualifications:

• 1) Proven experience managing design changes in a regulated medical device or IVD environment.
• 2) Demonstrated regulatory leadership on high-visibility core teams, with the ability to influence cross-functional decisions.
• 3) Hands-on experience with IVDR or EMDR compliance and documentation.

Required Education & Experience:

• Bachelor's degree in Life Sciences with 5+ years of regulatory affairs experience
• – or –
• Master's degree in Life Sciences with 3+ years of experience
• – or –
• Doctorate (PhD, PharmD, etc.) with 0–2 years of regulatory experience
• Strong understanding of global medical device regulations and product registration requirements
• Experience leading regulatory support for design change projects

Preferred Qualifications:

• RAC (Regulatory Affairs Certification)
• Prior experience submitting to FDA, Health Canada, and EU notified bodies
• In-depth knowledge of in-vitro diagnostic (IVD) regulatory requirements
• Strong interpersonal and communication skills with a proactive, solution-oriented approach

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Compunnel Inc. by 2x

Regulatory Affairs Specialist II – Electrophysiology (on-site)

Eden Prairie, MN $56,210 - $76,650 4 weeks ago

Regulatory Affairs Specialist II – Electrophysiology (on-site)

Regulatory Affairs Specialist II – Electrophysiology (on-site)

Plymouth, MN $60,000 - $120,000 23 hours ago

Regulatory Affairs Specialist II – Electrophysiology (on-site)

Plymouth, MN $60,000 - $120,000 3 days ago

Senior Regulatory Quality Specialist – Medical Devices (on-site)

Senior Specialist, Regulatory Affairs – Immunoassay Team

Plymouth, MN $120,488 - $205,000 2 weeks ago

Legal Assistant - Regulatory Affairs (Minneapolis, MN) (#3959)

Minneapolis, MN $23.62 - $48.04 1 week ago

Senior Regulatory Affairs Specialist - Peripheral Interventions

Maple Grove, MN $82,600 - $156,900 1 week ago

Associate Director of Regulatory Affairs

Eden Prairie, MN $165,000 - $225,000 5 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.