Regulatory Affairs Engineer

Regulatory Affairs Engineer

The company

I am delighted to work with a growing medical device company dealing in life saving critical equipment. Currently undergoing an exciting growth period, my client offer a great environment in which to gain new skills and grow your career.

About the role

The role is ideal for someone who has some strong previous Regulatory Affairs experience in medical devices (3 years+ minimum) and is looking for a responsible and busy role! The position will involve the leadership of regulatory submissions and providing expert regulatory advice across the business.

Ongoing training will be provided where necessary.

Required experience;

• Minimum BSc in a science/ regulatory affairs subject
• Strong previous work experience in a regulatory role (3 years+)
• Previous experience with ISO 13485 is essential
• Experience with 510k premarket notification is highly preferred
• Experience with class II or up medical devices would be preferred
• Strong communication and interpersonal skills/ ability to work with external businesses

Keywords: 

Regulatory affairs, senior, officer, advisor, medical device, equipment, critical, QA, submissions, FDA, 13485, 510k.

Harris Lord is acting as a recruitment agency for this role