Senior Risk Regulatory Affairs Manager (EU/FDA) - Medical Devices (Class II)
ProClinical is seeking a Senior Risk Regulatory Affairs Manager for a pioneering medical device company based in Birmingham on a permanent basis. The successful candidate will assist in preparation of regulatory submissions related to haemodialysis. The candidate will represent Regulatory Affairs on Product Development Teams (PDP) and/or Design Change Teams for the haemodialysis systems for use in the home and clinics in the company.
- Responsible to ensure regulatory compliance of the electro medical devices (QSR, ISO, CMDR and other applicable country regulations) are met through the development, implementation and delivery of company technologies.
- Own the process of compiling and completing dossiers for Class I, IIa and IIb devices
- develop relationship within the company to ensure data/evidence is available at the right time of submission
- Develop, manage and maintain the company device family - technical files, product specific design dossiers and compliance
- Keep up to date with changes in regulatory legislation within all countries
- Input to compliance and QMS across the site and develop the world class products
- Responsible to assess regulatory impacts of the design and manufacturing changes and prepares/submits 510(k)s, NFJs, DOC's and other country specific documentation as needed.
- Responsible to ensure all product labelling meets regulations through external materials i.e. Marketing brochures, intranet/internet publications, User documentation etc.
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.
- Performs advanced areas of work for the professional field. Able to manage multiple projects, communicate updates, and meet milestones in a timely fashion. Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.
- Strong communication skills to communicate clearly and professionally to various levels of management throughout the business.
Skills and Requirements:
- Degree Qualified; BSc, MSc or PhD in related discipline, or advanced degree, where required. Certification may be required in some areas.
- 8-10 years of Regulatory experience with electro medical devices (ideally within Class I, IIa, IIb medical devices)
- Experience with EU/EMA and U.S. FDA 510k submissions required.
- Knowledge and experience with global registrations is a plus
- Demonstrates a good grasp of QMS knowledge and quality and lean principles and applies through successful completion of assignments. Value stream mapping experience a plus.
- Strong interpersonal, communication and organizational skills required
- Ability to build and work within a team, Liaise with notified bodies
- Must be able to set priorities as well as adapt to changing priorities
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 Badria Kahie on +44 203 8718 094 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.