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General Contact Details - Headquarters UK

 

Flexicare Medical Limited
Cynon Valley Business Park, Mountain Ash,
Mid Glamorgan. CF45 4ER

United Kingdom

 

Tel: +44 (0)1443 474647

Fax: +44 (0)1443 474222

Email: enquiries@flexicare.com

 

Click here to view directions and a map to Flexicare Medical Limited.

 


 

Recruitment

Regulatory Affairs Manager

Salary: Negotiable
Location: South Wales
Job Type: Permanent

Flexicare is a leading UK manufacturer of medical devices. Backed by over 30 years experience in design and development, supported by a modern manufacturing facility we have well established brands in the global market place and are a well-known manufacturer and provider of a large and diverse range of quality consumables which are used throughout the Secondary and Primary care sector. We have a proven track record of providing value solutions simultaneously with clinical quality.

We are based in South Wales within a purpose built plant covering 48,000sq feet incorporating a clean room, warehousing and
office facilities.

Prime Function
The Regulatory Affairs Manager is responsible for the leadership and support of the Regulatory personnel. He/she participates in all activities relating to registration requirements and line extension indications.

Responsible To
Quality Regulatory & Technical Director

Duties and Responsibilities
1. Keep up to date with market trends and new developments utilizing information for business improvement
2. Careful planning to achieve accurate and timely results
3. Recognize recurring issues and analyses their causes in order to reach a solution
4. Responsible for coordination & preparation of regulatory submissions and strategies
5. Develop & maintain regulatory knowledge of European, FDA and country specific regulations
6. Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely
product approvals
7. Participate in product teams with regard to implementation of regulatory requirements
8. Manage transposition of international standards into company product related requirements
9. Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the
product development planning
10.Update licensing and collect information on registration instructions and regulations
11.To manage the duties and activities of the Regulatory Assistant and Compliance Engineer.

To apply for this position please email your full CV to recruitment@flexicare.com

Department Contacts

Customer Services Department

Tel: +44 (0)1443 471580

Email: enquiries@flexicare.com

 

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