Join our client's well-established Consumer Healthcare company in the Bucks/Berkshire area as a Regulatory Affairs Specialist (Medical Devices). This full-time hybrid role offers a dynamic work environment and the chance to contribute to a growing team.
Location: Hybrid - Bucks/Berkshire area
Salary/Benefits: Competitive pay, bonuses, and benefits
Key Responsibilities:
- Develop and implement regulatory strategies for EMEA and global markets.
- Provide guidance to product development teams.
- Coordinate regulatory deliverables with R&D, Marketing, and local teams.
- Prepare technical files and submissions for product certification.
- Represent Regulatory Affairs within the Healthcare division.
- Advise on product acquisitions and distributor agreements.
- Maintain communication with regulators and stakeholders.
- Stay updated on regulatory changes to ensure compliance.
- Support audits alongside the quality assurance team.
Experience & Requirements:
- Bachelor's degree or higher in a relevant field.
- Minimum of 5 years in Class I-III Medical Devices.
- Strong knowledge of MDD & MDR regulations.
- Experience with SaMD is highly desirable.
- Familiarity with Notified Bodies.
- Proficiency in English is essential.
Company Culture: Work with a team that values innovation, collaboration, and professional growth.
To Apply: Please send your resume and cover letter or contact Glen Fairbrother at 02079401212