| Location: Wokingham | Salary: Negotiable |
| Sector: Pharmaceuticals, Client Delivery, Medical Devices | Specialism: |
| Type: Contract | Contact: Matt Scott |
Regulatory Affairs Specialist
Location - Wokingham
Duration - 9 Months
Brief
Regulatory Affairs Specialist needed for a multinational medical device's organisation based in Wokingham who are looking to employ an experienced and well-rounded Regulatory Affairs Specialist that takes pride in their work with an in-depth knowledge of Medical Devices.
What the role entails:
Some of the main duties of the Regulatory Affairs Specialist will include:
- Ensures compliance of our devices with regulatory agency regulations and interpretations.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Prepares necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Conducts searches of existing files for requested information.
- Maintains and archives all EU regulatory documentation.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
- Partners with internal and external local, regional and global business partners, including Notified Bodies, Competent Authorities and Trade Associations.
- May take certain responsibilities in the Ethicon EU Authorized Representative organization and act as Local Actor Administrator.
What experience you need to be the successful Regulatory Affairs Specialist:
- 2-4 years of medical device industry or medical field experience and a bachelor's or master's degree is preferred
- Verbal and written communication skills.
Other desirables:
- Working knowledge of EU Medical Device regulatory matters including Medical Devices Directives (MDD, AIMDD) and Medical Device Regulation (MDR).
- Project Management skills (Leading Projects)
- Analytical problem-solving skills
- Proactively addressing challenges
- Able to work in a team and within a global network
- Able to present to internal and external audiences
This really is a fantastic opportunity for a Regulatory Affairs Specialist to progress their career. If you are interested, please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.
