This job has ended. Find similar jobs.

R& D Regulatory Affairs Manager

Posted 1 February by Clinical Professionals Limited Easy Apply Ended

R& D Regulatory Affairs Manager

Location- Hamburg

Job title- 18 Month Contract

Salary- Competitive

This global market leading client of Med Tech Professionals is looking for a Regulatory Affairs Manager to join their Research and Development Department at their site in Hamburg, on contract for 18 months.

The company specialise in the production of Medical Devices, specifically endoscopes and are looking for a dynamic candidate to join their company, to start as soon as possible

Your responsibility:

• Ensure compliance with regulatory requirements (MDD, FDA, PAL, CFDA) in collaboration with the development departments within the product development process

• Develop registration strategies for Medical Devices

• Participate and collaborate in Design Reviews

• Coordinate of all necessary regulatory affairs activities, including approval and maintenance, as well as coordination with the respective departments, suppliers and notified bodies

• Preparation of documentation for product approvals

• Examination and approval of development and accompanying documents from the regulatory point of view


• University with a technical orientation or comparable work experience in the field of regulatory affairs

• Knowledge of international approval requirements

• Knowledge of the relevant product standards (IEC 60601, 62304, etc.)

• Experience in project management

• Strong communication skills

• English fluently in speech and writing

If this role is not suited to you, please feel free to share the details within your professional network as we do operate a generous bonus referral scheme should we then go on to place someone that you recommend to us.

Regulatory Affairs, Germany, Hamburg, Medical Devices, IVD, ICE 60601, ICE 62304, RA, Regulatory Affairs Manager, MDD, IVD, PAL, FDA, CFDA,

Required skills

  • R& D Regulatory Affairs Manager

Reference: 34377283

Bank or payment details should not be provided when applying for a job. is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job