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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 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.
We're looking for a candidate with a strong background in regulatory affairs, preferably with experience in the medical device industry. You'll need to have excellent leadership skills, attention to detail, and the ability to manage competing priorities and workloads.
About YouWe're looking for a candidate with the following qualifications and experience:
- 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.
We offer a competitive salary and benefits package, including a contributory pension scheme, medical cash back plan, life assurance, and annual performance bonus. If you're passionate about making a difference in the world and have the skills and experience we're looking for, please apply.
