Regulatory Affairs Manager Medical Devices / IVD

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].