Regulatory Affairs Specialist

2 weeks 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 reputation for improvement, ethical leadership, and commitment to quality and safety.

We're passionate about making a difference in the world and investing in talented people to create world-class products and services. Our company culture is built on collaboration, teamwork, and open communication, making us a great place to work.

Job Description

We're seeking a Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you'll play a pivotal 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.
  • Maintaining all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, and regulatory submissions.
  • Providing regulatory support for sales and commercial activities.
  • Leading interactions with Notified Bodies on regulatory affairs matters.
  • Supporting all communications with regulatory authorities.
  • Leading regulatory transition projects and other significant regulatory initiatives.

We're looking for a candidate with a strong background in regulatory affairs, excellent leadership skills, and the ability to independently take initiative and complete tasks. If you have a passion for learning and want to build a career with a company that values its employees and is dedicated to making a positive impact in the world, we encourage you to apply.

About You

We're looking for a candidate with the following experience, skills, and attributes:

  • Bachelor's degree in a scientific, engineering, legal, or regulatory discipline.
  • Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency.
  • 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.
  • In-depth understanding of the relationship between international standards and regulatory requirements.
  • Comprehensive knowledge of EN ISO 13485.
  • Current specialist knowledge of medical device regulatory requirements in the EU and UK.
  • Familiarity with EN ISO 14971.
  • Experience working within a Quality Management System certified to EN ISO 13485.

We offer a competitive package, including a contributory pension scheme, medical cash back plan, life assurance, and annual performance bonus. If you're passionate about regulatory affairs and want to join a company that values its employees, we encourage you to apply.

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