Senior Manager Regulatory Affairs

Connect Life Science; Minneapolis (MN); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Benefits

Job summary

Connect Life Science is seeking a Senior Regulatory Affairs Manager to lead US RA operations, including FDA submissions, with hybrid work and some travel to Minneapolis. The role includes mentoring a small RA team and coordinating with internal stakeholders on regulatory strategy.

The ideal candidate will have 8+ years in Medical Device regulatory affairs, deep knowledge of US submissions (510(k), PMA, IDE), and prior management experience to drive partnerships and ensure timely product

Qualifications

• 8+ years in regulatory affairs for medical devices
• Experience with Class II devices
• US submissions knowledge: 510(k), PMA, IDE
• Experience managing RA teams

Responsibilities

• Lead US Regulatory Affairs operations, including FDA submissions
• Manage, hire, train and develop a growing RA team (currently 4)
• Liaise with internal, partner, and regulatory stakeholders
• Write, review, and compile regulatory documentation
• Ensure compliance with Class II device regulatory requirements
• Collaborate with R&D and Quality on NPD and submissions

Skills

Regulatory affairs

Team leadership

Cross-functional collaboration

Job description

We’re partnered with a mid-size Class II Medical Device business looking for a Senior Regulatory Affairs Manager. This is a fantastic opportunity to join a busy, energetic team with scope to grow and shape the direction of the RA function.

The company are aiming to complete 510(k) for their device in 2027 and have new products in the pipeline for 2027 and beyond.

Role Overview

• Full time Permanent Opportunity
• Start Date: August/September 2026
• Location: Hybrid with some travel to Minneapolis, MN
• Competitive Salary + Bonus + Benefits
• US-Based candidates with right to work only

What You’ll Be Doing

• Leading the business’ US Regulatory Affairs operations, including submissions to FDA
• Managing, hiring, training and developing a small but growing RA team (currently 4)
• Liasing with Internal, Partner, and Regulatory stakeholders
• Writing, reviewing, and compiling regulatory documentation
• Ensuring compliance with Class II device regulatory requirements
• Working cross-functionally with R&D and Quality on strategic projects including New Product Development and Submissions

What We’re Looking For

• 8+ years of Regulatory Affairs experience in Medical Devices, ideally with Class II experience
• Strong knowledge of RA processes across US markets (510(k), PMA, IDE etc.
• High attention to detail, excellent organisation, and ability to manage multiple priorities
• Previous Management of RA teams