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Regulatory Affairs Manager – Medical Devices IVD
Job Location:
Job Location:
Indianapolis, IN - USA
Salary:
Not provided by the employer
Salary:
Posted:
17 September 2026 (Yesterday)
Posted:
Application Deadline:
15 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
Required Skills:
Regulatory Submission Medical Device/IVD 510(k)/PMA/Pre-Sub/IVDR
