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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 improvement, ethical leadership, and commitment to quality and safety.
We're passionate about making a difference in the world and investing in talented people to create world-class products and services. Our company culture is built on collaboration, teamwork, and open communication, making us a great place to work.
Job DescriptionWe're seeking a Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you'll play a pivotal 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.
- Collaborating with regulatory authorities to achieve successful product registrations.
- Developing and implementing regulatory strategies for New Product Development (NPD) projects.
- Maintaining all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, and 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.
We're looking for a candidate with a strong background in regulatory affairs, excellent leadership skills, and the ability to independently take initiative and complete tasks. If you have a passion for learning and want to build a career with a company that values its employees and is dedicated to making a positive impact in the world, we encourage you to apply.
About YouWe're looking for a candidate with the following experience, skills, and attributes:
- Bachelor's degree 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.
We offer a competitive package, including a contributory pension scheme, medical cash back plan, life assurance, and annual performance bonus. If you're passionate about regulatory affairs and want to join a company that values its employees, we encourage you to apply.
