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