Senior Regulatory Affairs Specialist

1 month ago

Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time
About Us

Welland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.

We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our team is dedicated to delivering high-quality services and products that make a positive impact in the world.

Job Description

We are seeking a Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in supporting the business by developing regulatory strategies for new product development and registrations.

Your responsibilities will include:

  • Leading a regulatory team to ensure compliance with all relevant regulations and standards.
  • Collaborating with regulatory authorities to achieve successful product registrations.
  • Developing and implementing regulatory strategies for New Product Development (NPD) projects.
  • Overseeing the maintenance of all regulatory documentation.
  • Providing regulatory support for sales and commercial activities.

You will have the opportunity to work on a variety of projects, including:

  • Leading regulatory transition projects.
  • Developing submission strategies for NPD projects.
  • Overseeing regulatory decisions related to change control.

We are looking for a candidate with:

  • A Bachelor's degree in a scientific, engineering, legal, or regulatory discipline.
  • Previous experience in a Quality Assurance or Regulatory Affairs role.
  • Demonstrable experience working with EU MDD/MDR Class I and/or Class II devices.
  • Proven experience with medical device technical files and EU MDD/MDR requirements.

We offer a competitive salary and benefits package, including a contributory pension scheme, medical cash back plan, and life assurance.

If you are a motivated and experienced regulatory professional looking for a new challenge, please apply for this exciting opportunity.

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