Regulatory Affairs Executive, Medical Devices
Salary: upto £37,000 PA plus bonus, healthcare, pension etc.
Our Client, a major Medical Devices company who are experiencing significant growth at this time; are looking to appoint a RA Exec, who will play a key role in the development of the department and venture into new product ranges.
This involves maintaining an awareness of regulatory requirements, advising the business on regulatory topics and supporting NPD projects teams to obtain relevant registrations, clearances and licences.
- Supporting registrations and licences in line with relevant regulatory frameworks to enable product sales. This includes organising any necessary testing; submission of dossiers and also ensuring suitability of product labelling.
- Maintaining an awareness and ensure compliance with relevant regulations and laws in all markets.
- Monitor and communicate changes to applicable regulatory requirements
- Manage REACH tonnage reporting
- Track / report on assigned projects i.e. timelines/ costs
- Liaising with relevant country contacts Medical Devices
- Ensuring regulatory compliance of product labelling and also advertising
- Managing relevant technical documentation and files
- Interacting with consultants as and when required
- Reviewing technical documentation from all sources to ensure regulatory requirements are met i.e. R+D/external labs /consultants
- Handling post market reporting (Vigilance) Pharmaceutical
- Preparing and submission of registration dossiers (using third parties as necessary).
- Interacting with and advising project teams as assigned
- Responding to enquiries from internal and external stakeholders
- Providing advice on quality and regulatory requirements to key stakeholders as appropriate.
- Supporting general responsibilities of the regulatory department
- Working with external stakeholder contacts i.e. regulatory and certification agencies, industry organisations and business partners
- Manage BPR dossiers
- Author of SDS
- Conducting CLP assessments
- Interactions with Notified Body
- Will hold a Degree in a relevant, Scientific discipline
- Will have experience working in an RA based role in a Medical Devices (iso 13485 setting)
- Having an understanding in infection control/Microbiology is highly desirable
- Good Project Management experience and experience in Microsoft applications.
- Strong interpersonal / communication skills, with the ability to asses and translate technical data.