Regulatory Manager / Senior Regulatory Manager - Devices (Class III) and CE Markings

Highly Competitive Salary
Sep 29, 2016
Oct 27, 2016
David Nixon
Result Type
Position Type
Full Time

Regulatory Affairs Senior Manager - Devices - Class III; my client is a diversified healthcare organisation and global manufacturer of Class III devices. They are looking for a Senior Regulatory Manager to drive registration of new products, maintenance of technical files and obtaining of CE markings for Europe. 

You will have extensive experience within the field of devices registration and a desire to work within a dynamic environment. Class III device registration experience and CE Marking experience is essential for this position. 

Job Role:  

This Senior Regulatory Manager job role will include some key accountabilities that are:  

- Provides clear, constructive regulatory advice and guidance to global project and regulatory teams.
- Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
- Independently and without supervision, prepares complex regulatory documents for product approval in EAME.
- Maintains Design Dossiers and Technical Files ensuring contents are current and accurate.
- Performs peer review of complex regulatory documents.
- Establishes strong and effective relationships with global regulatory teams thereby ensuring RA activities are in line with global and regional business priorities.
- Has regulatory expertise and knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
- Provides effective technical/scientific input to the Brand Teams, supporting the development and review of compliant promotional materials.
- Reviews labelling and packaging components to ensure accuracy and compliance with governmental regulations.
- Working with regional commercial teams, agrees priorities and clearly conveys project timelines, risks and opportunities.
- Provides input into the regulatory implications of EAME Medical Affairs study proposals, both company-sponsored and Investigator-led.

Experience and Qualifications: 

- A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved.
- Sound Medical Device experience, including a successful track record in the registration and maintenance of products within Europe.
- Sound knowledge of relevant Quality Standards. Direct interaction with competent authorities and Notified Bodies.
- Excellent organisational/ planning and negotiation skills
- Excellent communication skills, both written and verbal (in English).
- Good interpersonal skills and the ability to influence others without formal authority.
- Ability to work effectively and collaboratively across the global organisation and cross-functionally.
- Ability to coordinate and synchronize multiple projects and be flexible in changing daily workload priorities.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call David Nixon on +44(0)203 0789 544 or upload your CV on our website . Full job description available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.