Senior Regulatory Specialist

Hobson Prior is seeking a highly skilled and experienced Regulatory Affairs Manager to join their team. The successful candidate will play a crucial role in ensuring that our medical devices meet all regulatory requirements, with a strong focus on compliance with the European Medical Device Regulation (MDR). This position involves managing regulatory submissions, maintaining regulatory documentation, and providing strategic guidance to cross-functional teams.

Please note that to be considered for this role you must have the right to work in this location.

Location: Düsseldorf
Type: Hybrid

Key Responsibilities:

1. Regulatory Compliance: Ensure that all medical devices comply with the European MDR and other relevant regulations, standards, and guidelines.
2. Regulatory Submissions: Prepare, review, and submit regulatory documents, including Technical Files, Design Dossiers, and Clinical Evaluation Reports, to regulatory authorities.
3. Regulatory Strategy: Develop and implement regulatory strategies to support product development, registration, and lifecycle management.
4. Documentation Maintenance: Maintain up-to-date regulatory documentation, including regulatory filings, certificates, and product labels.
5. Cross-functional Collaboration: Work closely with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to ensure regulatory requirements are integrated into product development and commercialization processes.
6. Regulatory Intelligence: Monitor and interpret regulatory changes and trends, and provide guidance to the organization on potential impacts.
7. Audits and Inspections: Support and participate in internal and external audits and inspections, ensuring regulatory compliance and readiness.
8. Training and Mentorship: Provide training and mentorship to junior regulatory staff and other departments on regulatory requirements and best practices.

Key Skills and Requirements:

1. Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs).
2. Minimum of 5 years of experience in regulatory affairs within the medical device industry.
3. In-depth knowledge of the European MDR and other relevant regulations (e.g., ISO 13485, ISO 14971).

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV.