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Senior Regulatory Affairs Specialist
1 month ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout Us:Welland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. With a rich history dating back to 1982, the group has grown through acquisitions and formations, establishing itself as a prominent player in the market.We bring innovative products to market that enhance the lives...
Senior Regulatory Affairs Specialist
2 months ago
About Welland Medical Ltd
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 company has a strong reputation for innovation, ethical leadership, and commitment to quality and safety.
Our Company Culture
We pride ourselves on a collaborative, team-oriented culture that fosters open communication and a passion for making a difference in the world. Our employees enjoy a range of benefits, including:
- 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 Leave - 25 Days Per Year Rising to 27 Days After 5 Years Service In Addition to Bank Holidays and An Extra Company Day
About the Role
We are seeking a highly skilled 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.
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
We offer a competitive salary and benefits package, including contributory pension scheme, medical cash back plan, life assurance, and annual performance bonus.
How to Apply
If you are a highly skilled and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.
