My client, an expanding Clinical Research Organisation are currently seeking to recruit a Regulatory Submissions Manager to join their Clinical Operations team. This position plays...
Rare opporunity to join a global medical device organisation as a Pre-market Regulatory Affaris Manager.
The primary responsibilities of the position are to ensure regulatory compliance of products, drive regulatory pre-market processes and activities (such as change control) and continue to develop strong working relationships with members of the Ostomy franchise. The person will be responsible for the management of global and regional pre-market regulatory Ostomy projects, including, but not exclusively, the regulatory aspects of new product development, product life cycle and changes to existing products.
Duties and Responsibilities:
- For medical device products under development and for product lifecycle changes liaise with Ostomy project development teams to ensure global RA requirements are included in the project plan and ensure high quality regulatory compliant pre- marketing documentation is prepared, e.g., for CE marking and 510(k) clearance according to the agreed timeline
- Make available technical information for international registrations to RA colleagues supporting commercialization globally
- Review sales training, promotional and advertising material, and labeling components
- Mentor and manage one or more Ostomy Regulatory Affairs Specialists
- Create new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
- Assist with global regulatory processes, such as Change Control, EU Technical File maintenance, GMDN, UDI, etc
- Regulatory/Quality experience in medical devices.
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
- Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971
- Demonstrate excellent communication skills
- Demonstrate strong organizational skills, including the ability to prioritize workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.