Overview In this Regulatory Affairs Device role, you will design regulatory strategies to enable timely approvals for medical devices and manage submissions for INDs/CTAs and market variations. You will partner with RA, R&D, and Operations to steer product development and lifecycle decisions, and handle government interactions across global markets. You will review engineering and manufacturing change documents, ensuring compliance with EU MDR and Class IIb requirements. This position emphasizes strategic influence, cross-functional collaboration, and accountable submissions in a regulated environment.
Responsibilities- Develops device regulatory strategies to enable first-pass approvals under limited supervision
- Manages content strategy for regulatory submissions (INDs/CTAs, market applications, variations) with limited supervision
- Builds and maintains relationships across Regulatory Affairs, Operations, and R&D
- Represents RA Device on development and lifecycle teams to influence and advise peers in RA, R&D, and Operations
- Files necessary applications and handles government interactions for regulatory approval
- Reviews engineering study protocols/reports and validation study protocols/reports
- Reviews and approves manufacturing changes for Class IIb (EU) medical devices
Key requirements- Experience supporting device submissions, licenses, and variations in non-US regions (JAPAC, MEAR, LATAM)
- Experience responding to health authority questions related to submissions
- Advanced degree may be required and 3-5 years of direct field experience
- Recent experience with Class IIb medical devices in EU
- Proven track record of authoring/submission/approval of Class IIb variations/renewals
- Knowledge of EU MDR 2017/745 regulation
- Strong judgment and ability to work with limited supervision
- strategic mindset
- relationship-building
- negotiation and influencing
- Regulatory submissions (INDs/CTAs)
- EU MDR 2017/745 knowledge
- Class IIb medical device regulations
