Senior Regulatory Affairs (Medical devices)

MSI Pharma; Greater London; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Regulatory Affairs Specialist to join their dynamic team in a hybrid role. This position offers the opportunity to make a significant impact in the medical devices sector, focusing on Class I, II, and III products. You will develop and implement regulatory strategies for EMEA and global markets, guide product development, and ensure compliance with MDD and MDR regulations. If you have over five years of experience in regulatory affairs and a passion for self-care medical devices, this role could be your next career milestone. Don't miss the chance to shape the future of healthcare technology!

Benefits

Competitive Pay

Bonuses

Benefits

Qualifications

• 5+ years of experience with Class I-III Medical Devices.
• Strong knowledge of MDD & MDR regulations.

Responsibilities

• Develop and implement regulatory strategies for EMEA and global markets.
• Prepare technical files and submissions for product certification.

Skills

Regulatory Strategy Development

Knowledge of MDD & MDR Regulations

Experience with Class I-III Medical Devices

Technical File Preparation

Audit Support

Proficiency in English

Education

Bachelor's Degree

Job description

Immediate Opportunity: Regulatory Affairs Specialist (Medical Devices)

Our client in the Buckinghamshire/Berkshire area is urgently seeking a Regulatory Affairs Specialist (Medical Devices) for a full-time hybrid role. This position offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices.

Location: Hybrid - Bucks/Berkshire
Salary/Benefits: Competitive pay, bonuses, and benefits

Key Responsibilities:

• Develop and implement regulatory strategies for EMEA and global markets.
• Guide product development and coordinate regulatory deliverables.
• Prepare technical files and submissions for product certification.
• Stay updated on regulations and support audits.

Experience & Requirements:

• Bachelor's degree or higher.
• 5+ years of experience with Class I-III Medical Devices.
• Strong knowledge of MDD & MDR regulations; SaMD experience is a plus.
• Proficiency in English and familiarity with Notified Bodies.
• UK citizens or candidates with the right to work in the UK only.

Candidates who are keen to work in self-care Medical devices (not Medtech) will find this opportunity more fulfilling.

Send your CV today for immediate consideration.