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Senior Regulatory Specialist
Cardiff
40,000 - 50,000
Yolk Recruitment is partnered with a pioneering medical device business during an exciting period of sustained expansion and has a new opportunity for a Regulatory Specialist to join the team.
The role offers not only the opportunity to be a part of a high growth, high innovation business in a rewarding field, but to make your mark in a lead role providing guidance on a wide range of regulatory affairs. You'll support NPD projects, guiding others to ensure product compliance and support audits, developing RA strategies to govern the continued development of existing products as well as new product development as they continue to grow in existing and new markets.
This is what you'll be doing as Regulatory Specialist
- Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
- Work with colleagues throughout the business: R&D, Legal, Sales and Operation.
- Collaborate with NPD teams, reviewing and approving documents, and participating in design and stage gate reviews.
- Monitor new standards and ensure NPD meets recognized consensus standards.
- Participate in CAPA teams to resolve issues and ensure continuous compliance.
- Prepare and maintain technical files to meet regulatory requirements.
- Develop and implement regulatory strategies for NPD and existing products.
And here's what you'll need:
- Experience in Regulatory Affairs in Class 1/+ medical devices for territories including FDA, UKCA and MDR.
- Knowledge of ISO13485, ISO14791, and maintenance of the risk management framework
- Proficiency in preparing submissions and communicating with regulatory organizations
- Ability to develop and implement regulatory strategies for NPD and existing products.
- BEng/BSc in Engineering or Science with RA experience in the medical device industry.
- Excellent communication skills to collaborate with cross-functional teams.
- Proficient in managing day-to-day RA activities and tasks independently.
- Positive and optimistic attitude, with a focus on customer and patient safety and usability.
And this is what you'll get in return
- Competitive salary, increasing through annual statutory and performance review
- Matched 5% pension
- Flexible benefits package
- Free on-site parking.
- 25 days annual leave plus public holidays.
- Employee Assistance Programme for you and your immediate family
- Training and Career Development Opportunities
- State of the art premises, free parking
If you want to make an impact in your next Regulatory role, apply now!
*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.*
