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Job Details

Regulatory Affairs Associate

Company: Regulatory Professionals
Location: Buckinghamshire
Reference: JO-1802-403679
Closing Date: 16 Apr 18
Type: Full Time
Salary (£): Negotiable
Benefits: flexible dependent on experience

Job Summary:

Regulatory Affairs Associate/ Specialist A rapidly expanding medical device company are seeking a Regulatory Affairs Associate/Specialist to join their team.


Regulatory Affairs Associate/ Specialist
Medical Devices
High Wycombe, Buckinghamshire
Salary: flexible dependent on experience
Job Reference: JO-1802-403679
*Flexibility on title and salary*

A rapidly expanding medical device company are seeking a Regulatory Affairs Associate/Specialist to join their team. With only 20-30 current employees, this client are looking to increase their headcount substantially over the next couple of years and expand into new markets and launch new products. At this time of growth this is a great opportunity for candidates with 2-3 years' worth of Regulatory, medical device experience as they provide vast development opportunities.

Main Responsibilities include:
- Submitting and maintaining regulatory approvals
- Prepare and submit applications to EU, USA, and other global markets
- Ensure compliance with applicable regulations for company's medical devices
- Involvement in ISO13485 and ISO14971 quality management systems
- Submitting FDA 510(k)'s.

Required Experience:
- Between 2-4 years Regulatory experience, specifically having worked on medical devices
- Strong knowledge of EU markets and regulations
- Good experience of ISO13485 and ISO14971 quality management systems
- Experience of submitting FDA 510(k)'s is highly desirable
- Knowledge of global markets (desirable).

If this role is not quite right for you, but you're interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then you'll receive £250 worth of vouchers of your choice.

Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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