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Regulatory Affairs Director
4 weeks ago
Oxford, Oxfordshire, United Kingdom Lenntech Search Full timep>Lenntech Search is partnering with a pioneering software medical device company to find an experienced Regulatory Affairs Manager.\/h3>Main Responsibilities\/h3>ul>li>Oversee company regulatory submissions to the FDA and other regulatory bodies.\/li>li>Prepare and submit applications and reports to relevant regulatory agencies.\/li>li>Respond to reviews...
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Oxford, Oxfordshire, United Kingdom Lenntech Search Full timep>Lenntech Search is partnering with a pioneering software medical device company to find an experienced Regulatory Affairs Manager.\/h3>Main Responsibilities\/h3>ul>li>Oversee company regulatory submissions to the FDA and other regulatory bodies.\/li>li>Prepare and submit applications and reports to relevant regulatory agencies.\/li>li>Respond to reviews...
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Regulatory Affairs Director
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Senior Director Regulatory Affairs
2 months ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...
Regulatory Affairs Specialist
2 months ago
Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.
As a key member of the regulatory team, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring compliance with international regulatory requirements.
This is a hybrid role with twice weekly site visits, offering a unique blend of office and on-site work.
We are seeking an experienced regulatory professional with proven expertise in MDR, particularly for Class III devices and a strong understanding of global regulatory frameworks.
Key responsibilities include:
- Coordinate worldwide product registration submissions and ongoing maintenance
- Support regulatory activities related to change note approvals and complaint file reviews
- Assist in delivering new and existing products in compliance with global regulatory standards
Requirements:
- Proven experience in a Regulatory Affairs role in Medical Devices
- Knowledge and experience of Class III Medical Devices
- Knowledge of Product Registrations, preferably Worldwide
If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today.
