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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
Welland Medical Ltd is a leading company in the healthcare and medical equipment industry, with a strong reputation for quality and safety. Our company culture is built on collaboration, teamwork, and open communication, and we are passionate about making a positive impact in the world.
About the RoleWe are seeking a highly skilled and experienced 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.
Main Responsibilities- Regulatory Leadership: Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
- Regulatory Collaboration: Collaborate with regulatory authorities to achieve successful product registrations.
- Regulatory Strategy: 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.
- Regulatory Documentation: Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
- Regulatory Support: Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
- Regulatory Interactions: Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
- Regulatory Communications: Support all communications with regulatory authorities.
- Regulatory Projects: Lead regulatory transition projects and other significant regulatory initiatives.
- Regulatory Guidance: Lead submission strategies for NPD projects and offer guidance on R&D product development.
- Regulatory Decision-Making: Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
- Regulatory Quality Assurance: Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
- Regulatory Auditing: Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
- Regulatory Vigilance: Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
- Regulatory Monitoring: Monitor and review changes in regulations and standards, assessing their impact on the business.
- Regulatory Compliance: Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
- Regulatory Procedures: Create and maintain procedures to ensure ongoing regulatory compliance.
- Regulatory Training: Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
- Regulatory Team Management: Manage, support, and mentor the RA team.
We are looking for a highly skilled and experienced Senior Regulatory Affairs Specialist with the following qualifications and attributes:
- Education: Bachelor's degree (or equivalent) in a scientific, engineering, legal, or regulatory discipline.
- Experience: Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency.
- EU MDD/MDR Experience: Demonstrable experience working with EU MDD/MDR Class I and/or Class II devices.
- Regulatory Knowledge: Proven experience with medical device technical files and EU MDD/MDR requirements.
- International Standards: In-depth understanding of the relationship between international standards and regulatory requirements, including the role of harmonized standards.
- EN ISO 13485: Comprehensive knowledge of EN ISO 13485.
- Medical Device Regulations: Current specialist knowledge of medical device regulatory requirements in the EU and UK.
- EN ISO 14971: Familiarity with EN ISO 14971.
- Quality Management System: Experience working within a Quality Management System certified to EN ISO 13485.
- Leadership Skills: Strong leadership skills with the ability to independently take initiative and complete tasks.
- Attention to Detail: Exceptional attention to detail, with a clear understanding of the broader implications of actions and decisions.
- Communication Skills: Excellent written and verbal communication skills, effective across all levels of the organization and with external contacts.
- Time Management: Ability to manage competing priorities and workloads to meet deadlines.
