Remote Principal Regulatory Affairs Specialist

MiniMed; United States; Remote; USD 109,000 - 205,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Employee Stock Purchase Plan

Job summary

MiniMed is seeking a Principal Regulatory Affairs Specialist to guide regulatory pathways for diabetes devices and software, coordinating global submissions to US and EU authorities. The role emphasizes leadership in strategy, writing, and cross-functional collaboration, with remote work and limited travel.

The successful candidate will bring extensive medical device regulatory experience, strong negotiation skills, and a track record of successful submissions across Class II and III devices.

Qualifications

• Minimum 7 years of medical device regulatory experience with Bachelor’s degree.
• Or minimum 5 years of medical device regulatory experience with an advanced degree.
• History of successful device submissions in the US and EU with both Class II and Class III devices.

Responsibilities

• Develop and refine least burdensome regulatory strategies for Diabetes devices across US, EU and global teams.
• Apply regulatory standards and guidance to product strategies and submissions.
• Demonstrate strong project management and execution of regulatory items.
• Lead negotiations with regulatory authorities to secure approvals/clearances.
• Build relationships with regulatory agencies for pre-submissions and submissions.
• Provide regulatory input to product lifecycle planning.
• Inform international regulatory staff to align strategies across business teams.
• Other duties as assigned.
• Position is 100% remote.
• Travel up to 10% as allowed.

Skills

Regulatory strategy

Regulatory submissions

Project management

Regulatory writing

Regulatory negotiations

Cross-functional collaboration

Regulatory communications

Education

Bachelor’s degree

Advanced degree

Tools

MS Office

MS Project

Adobe Acrobat

Job description

MiniMed is seeking a Principal Regulatory Affairs Specialist to guide regulatory pathways for diabetes devices and software, coordinating global submissions to US and EU authorities. The role emphasizes leadership in strategy, writing, and cross-functional collaboration, with remote work and limited travel.

The successful candidate will bring extensive medical device regulatory experience, strong negotiation skills, and a track record of successful submissions across Class II and III devices.