Regulatory Affairs Manager
|Job Title:||Regulatory Affairs Manager|
|Location:||Wigan, Greater Manchester|
|Contact Name:||Emma Brighouse|
|Job Published:||September 29, 2020 10:56|
This specialist manufacturing business who produce an extensive range of health care products across three UK operations, are looking to attract into their business a Regulatory Affairs Manager who will ensure compliance of their globally distributed products.
This is an exciting opportunity for a driven individual who will ensure regulatory processes and activities continue, whilst developing strong working relationships with customers.
As Regulatory Affairs Manager, typical responsibilities will be to: -
- Develop regulatory submissions, ensuring that timescales and regulatory pathways are understood.
- Support the Product Management and Commercial Teams by establishing regulatory requirements in the chosen market.
- Negotiate and communicate with relevant regulatory bodies.
- Create and maintain technical files.
- Liaise with Product Management and Quality Assurance Teams to ensure requirements are met.
- Play a key role when products are being developed to ensure RA requirements are included in the project plan.
The candidate will: -
- Have gained their experience of RA within a highly regulated manufacturing environment.
- Have a strong understanding of ISO 13485.
- Have a strong knowledge of submission paperwork for global markets.
- Be experienced working with notified bodies and regulatory agencies.
On offer to the successful candidate is: -
- Competitive salary based on experience.
- 25 days holiday plus bank holidays
- 4 x salary life assurance
- Working hours are 9-5 Monday to Friday
- Great working environment
To apply, please follow the 'apply now' button to send your CV to Morgan Ryder Associates.
PLEASE NOTE OUR OFFICES ARE NOW CLOSED UNTIL FURTHER NOTICE
IF YOU NEED TO CONTACT US, PLEASE DO SO VIA EMAIL.
PLEASE DO NOT CALL THE OFFICE
At Morgan Ryder we can provide you with a full range of employment opportunities from short term and fixed term temporary vacancies to permanent positions.
We recruit for companies that operate in the following industries: Food and Drink Manufacturers, FMCG, Packaging, Engineering, Automotive, Aerospace, Warehousing, Logistics, Waste Management, Petro Chemical, Pharmaceutical, Power & Renewable Energy.
Please note that calls to and from the offices of Morgan Ryder Associates Ltd. may be monitored or recorded. This is to ensure compliance with regulatory procedures, record business transactions and for training purposes.
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