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Regulatory Affairs Specialist
2 months ago
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 reputation for innovation and quality.
We are passionate about making a difference in the world through our products and services. Our company culture is built on collaboration, teamwork, and open communication, with a focus on delivering exceptional results for our clients.
Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in supporting the business by developing regulatory strategies for new product development and registrations.
Your responsibilities will include:
- Leading a regulatory team to ensure compliance with all relevant regulations and standards across the business.
- Collaborating with regulatory authorities to achieve successful product registrations.
- Developing and implementing regulatory strategies for New Product Development (NPD) projects.
- Overseeing the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, and other regulatory submissions.
- Providing regulatory support for sales and commercial activities.
- Leading interactions with Notified Bodies on regulatory affairs matters.
- Supporting all communications with regulatory authorities.
- Leading regulatory transition projects and other significant regulatory initiatives.
- Overseeing regulatory decisions related to change control.
- Supporting Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification.
- Participating in auditing processes and providing regulatory guidance.
- Supporting vigilance reporting and Field Safety Corrective Actions (FSCA).
- Monitoring and reviewing changes in regulations and standards.
- Ensuring compliance with relevant regulations and standards for Instructions for Use (IFUs), labelling, marketing materials, and technical documentation.
- Creating and maintaining procedures to ensure ongoing regulatory compliance.
- Advising and training colleagues on regulatory requirements.
- Managing, supporting, and mentoring the RA team.
We are looking for a highly skilled and experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have:
- A 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.
- 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 and excellent written and verbal communication skills.
