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Regulatory Affairs Specialist

2 months ago

Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time
Join Our Team at Welland Medical Ltd

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Welland Medical Ltd. 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.

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.
  • Develop 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.
  • Create and maintain procedures to ensure ongoing regulatory compliance.
  • Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.

Requirements:

  • 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.
  • 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.
  • Current specialist knowledge of medical device regulatory requirements in the EU and UK.
  • Experience working within a Quality Management System certified to EN ISO 13485.
  • Additional qualifications in the field of medical device regulatory affairs.
  • Demonstrable experience as part of a project team implementing significant regulatory transitions.

What We Offer:

  • Contributory Pension Scheme (4% Employee and 5% Employer Contribution, increasing to 10% with service)
  • Medical Cash Back Plan
  • Life Assurance (4 x Annual Gross)
  • Annual Performance Bonus
  • Annual Pay Review
  • Cycle to Work Scheme
  • Employee Referral Scheme
  • Discounts on Selected Products and Services
  • Employee Assistance Programme – Health and Wellbeing
  • Annual Leaves - 25 Days Per Year Rising to 27 Days After 5 Years Service In Addition to Bank Holidays and An Extra Company Day

Location: Crawley