Regulatory Affairs Manager – Medical Devices / IVD

Our client, a world leader in biotechnology and life sciences, is looking for a “Regulatory Affairs Manager – Medical Devices / IVD”. Location: Indianapolis, IN (Hybrid - 2 Days Remote/ 3 Days Onsite) Job Duration: Long-Term Contract (Possibility Of Extension) Company Benefits: Medical, Paid Sick Leave, 401 (k) About the Role You will work closely with cross-functional teams to support regulatory submissions, product compliance, and regulatory strategies across key global markets, including the United States, European Union, and China.

The ideal candidate will have hands-on medical device or IVD regulatory experience and a strong understanding of regulatory pathways involving software, hardware, systems, and cybersecurity.

Key Responsibilities

Lead and coordinate regulatory submission activities for medical device and IVD products. Support U.S. regulatory pathways including 510(k), PMA, and FDA Pre-Submission activities. Support European regulatory activities, including IVDR requirements. Contribute to regulatory strategies and submission planning for new and existing products.

Compile, review, and coordinate technical and regulatory documentation. Partner with engineering, software, hardware, quality, product development, and other cross-functional teams. Manage activities across assigned product portfolios and identify and coordinate with key stakeholders. Required Qualifications 5+ years of relevant regulatory affairs experience; Experience with medical device regulatory submissions and/or regulatory strategy.

Strong project management and stakeholder management skills.

Preferred Skills

Experience supporting both new product development and post-market/on-market compliance. Experience with global regulatory strategies and technical documentation. If interested, please share your updated resume at [email protected]/[email protected].