Senior 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, which is built on a foundation of 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 highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our Quality Assurance department, you will play a pivotal role in supporting the business by developing regulatory strategies for new product development and registrations.

**Key Responsibilities:**

  • Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
  • Collaborate with regulatory authorities to achieve successful product registrations.
  • Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
  • Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
  • Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
  • Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
  • Support all communications with regulatory authorities.
  • Lead regulatory transition projects and other significant regulatory initiatives.
  • Lead submission strategies for NPD projects and offer guidance on R&D product development.
  • Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
  • Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
  • Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
  • Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
  • Monitor and review changes in regulations and standards, assessing their impact on the business.
  • Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
  • Create and maintain procedures to ensure ongoing regulatory compliance.
  • Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
  • Manage, support, and mentor the RA team.
About You

An ideal candidate for this position will have the following experience, skills, and attributes:

  • Bachelor's degree (or equivalent) 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, including the role of harmonized standards.
  • 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.
  • Strong leadership skills with the ability to independently take initiative and complete tasks.
  • Exceptional attention to detail, with a clear understanding of the broader implications of actions and decisions.
  • Excellent written and verbal communication skills, effective across all levels of the organization and with external contacts.
  • Ability to manage competing priorities and workloads to meet deadlines.

We're looking for a highly motivated and experienced professional to join our team. If you have a passion for regulatory affairs and a strong background in medical device compliance, we encourage you to apply.

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