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)

• Medical
• Paid Sick Leave
• 401 (k)

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.

• 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.

• 5+ years of relevant regulatory affairs experience;
  Experience with medical device regulatory submissions and/or regulatory strategy.
• Strong project management and stakeholder management skills.

• Experience supporting both new product development and post-market/on-market compliance.
• Experience with global regulatory strategies and technical documentation.