Senior Regulatory Specialist
- Employer
- Barrington James
- Location
- Worthing, West Sussex (GB)
- Salary
- Competitive Salary
- Start date
- 20 Sep 2019
- Closing date
- 20 Oct 2019
View more
- Discipline
- Regulatory Affairs, CMC, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
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Job Details
The purpose of this role is to provide and maintain regulatory support, supply regulatory input and data and ensure compliance with standards and medical device regulations worldwide.
- • Provide support for registration activity in your assigned geographic region(s) this includes (but is not limited to):
- o Developing registration and launch plans with the regional sales managers to ensure that
- o The preparation and submission of registration dossiers, and their submission and remediation.
- o Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications
- o Interpret existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures
- Ensure compliance to global regulatory requirements and company policies
- Provide input to Company activities including the risk management process, process and procedure improvements, management review and support new product development activities
- Review document and product changes for regulatory submission impact
- Support equipment, system and process development in-house and with suppliers
- Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. FDA, Notified Bodies etc)
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
Company info
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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