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Regulatory Affairs Specialist
2 months ago
Welland Medical Ltd is a leading company in the healthcare industry, and we're looking for a highly skilled Senior Regulatory Affairs Specialist to join our team.
About the Role:
- Develop and implement regulatory strategies for new product development and registrations.
- Manage the upkeep of all regulatory documentation and ensure compliance with relevant regulations and standards.
- Lead a regulatory team of two, ensuring compliance across the business.
- Collaborate with regulatory authorities to achieve successful product registrations.
- 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, dossiers, 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.
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.
- Current specialist knowledge of medical device regulatory requirements in the EU and UK.
- Experience working within a Quality Management System certified to EN ISO.
- Additional qualifications in the field of medical device regulatory affairs.
What We Offer:
- Contributory Pension Scheme.
- Medical Cash Back Plan.
- Life Assurance.
- 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.
How to Apply:
Please submit your application, including your resume and a cover letter, to [insert contact information].
