Role: Regulatory Manager - Medical Devices
Salary: Competitive + Benefits
Russell Taylor Group has a fantastic opportunity to join our clients Medical Device Company as Regulatory Manager. You will have Medical Device experience and worked with Class IIB or Class III Medical Devices.
- Act as back-up/deputy PRCC in lieu of Compliance Director.
- Generate Technical Files for new products.
- Update technical files as a results of changes to products or regulations, such as MDR,
- and ensure that CE marking is maintained.
- Conduct distributor approval.
- Conduct registration in new markets including MDSAP.
- Undertake Regulatory submissions including 510(k) for the United States.
- Prepare for and attend regulatory audits.
- Support the complaints function of the Quality team with regard to regulatory reporting and vigilance.
- Provide line management support, direction and coaching to regulatory team and conduct regular catch ups and annual Staff Development Reviews.
- Undertake any other duties of a regulatory nature including attending cross company meetings and providing advice to other departments.
- Essential Experience, Knowledge and Qualifications
- Degree in a scientific subject, preferably biology or chemistry or bioengineering.
- Regulatory experience in in a medical device company dealing with implantable devices.
- Experience supporting distributor approval in a medical device company.
- Desirable Experience, Knowledge and Qualifications
- Higher degree in a scientific subject
- Regulatory experience of Class III medical devices
- Knowledge of different sterilisation methods including Gamma and Ethylene Oxide (ETO)
- Knowledge of regulatory requirements for medical devices in global markets, particularly MDSAP
- Essential Skills and Behaviours
- Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
- Able to lead by example and act as a role model.
- Excellent written communication and presentation skills.
- Good organisation and leadership skills and attention to detail.
- A can do, customer-focused -attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.