Senior Regulatory Affairs Manager - Medical Devices

Michael Page (UK); England; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading recruitment agency is seeking a Regulatory Affairs professional in the medical device industry. You will develop regulatory strategies, oversee FDA and EU MDR submissions, and guide cross-functional teams. The role offers competitive compensation, hybrid working, and a package of benefits, including 25 days of leave and an on-site gym.

Benefits

Competitive package

25 Days leave + Bank holidays

Hybrid working

EV Scheme

On site Gym

Qualifications

• Extensive experience in the Medical Device industry focusing on Regulatory Affairs.
• Proven leadership ability.
• Experience with FDA and EU MDR submissions.

Responsibilities

• Develop and execute the regulatory strategy.
• Provide guidance for Product Safety Evaluation.
• Oversee regulatory submissions for FDA and EU MDR.
• Sign off on artwork, warnings, and safety documentation.
• Work cross-functionally with R&D for NPD pipeline.
• Assist teams with global expansion considering regulatory changes.

Skills

Extensive experience in Medical Device industry

Leadership

FDA submissions

EU MDR submissions

Job description

Overview

The client benefits amid rising demand in a high-growth market

A newly created position in their structure, with freedom to shape the role

About Our Client

Our client is a Medical Device business, headquartered in the UK.

Job Description

• Develop and Execute the regulatory strategy
• Provide guidance in relation to Product Safety Evaluation
• Oversee regulatory submissions for FDA and EU MDR
• Final sign off on artwork, warnings, and safety documentation
• Work cross functionally with R&D to foster a strong NPD pipeline
• Assist the teams with global expansion, considering changes in the global regulatory landscape

The Successful Applicant

• Extensive experience in Medical Device industry, focusing on Regulatory Affairs
• Proven leader
• FDA and EU MDR submissions experience

What\'s on Offer

• Competitive package. This is a new role, so that client is willing to listen to the market, and pay what the market dictates
• 25 Days leave + Bank holidays
• Hybrid working
• EV Scheme
• On site Gym