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Regulatory Affairs Specialist

2 months 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 strong tradition of improvement, ethical leadership, and total commitment to quality and safety.

We're proud of our company culture, built on collaboration, teamwork, and open communication. Our employees are passionate, driven, and committed to delivering the best possible results for our clients.

About the Role

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

You will be responsible for managing the upkeep of all regulatory documentation, ensuring compliance with relevant regulations and standards, and collaborating with regulatory authorities to achieve successful product registrations.

Main Responsibilities:

  • Lead a regulatory team, ensuring compliance with all relevant regulations and standards.
  • Develop and implement regulatory strategies for New Product Development (NPD) projects.
  • Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, and other regulatory submissions.
  • Provide regulatory support for sales and commercial activities.
  • Lead interactions with Notified Bodies on regulatory affairs matters.
  • Support all communications with regulatory authorities.
  • Lead regulatory transition projects and other significant regulatory initiatives.
About You

We're looking for a highly skilled and experienced Regulatory Affairs Specialist with a strong background in medical device regulations. You will have a Bachelor's degree in a scientific, engineering, legal, or regulatory discipline and previous experience in a Quality Assurance or Regulatory Affairs role.

You will have 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, and comprehensive knowledge of EN ISO 13485.

You will be a strong leader with excellent written and verbal communication skills, effective across all levels of the organization and with external contacts. You will have the ability to manage competing priorities and workloads to meet deadlines.

What We Offer

We offer a competitive salary and benefits package, including a contributory pension scheme, medical cash back plan, life assurance, and annual performance bonus. You will also have access to a cycle to work scheme, employee referral scheme, and free yearly flu vaccination.

We're committed to supporting your career development and offer opportunities for training and professional growth.