Regulatory Affairs Officer

Regulatory Affairs Officer

Life Sciences

Location Newcastle upon Tyne

Salary Very competitive salary & benefits

Contract Permanent

Reference CYRAO78

Date Posted

Consultant

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Regulatory Affairs Officer

As part of a continued expansion plan, our client a leading medical devices manufacturing organisation are seeking to recruit a Regulatory Affairs Officer on a permanent basis.

The Regulatory Affairs Officer is responsible for carrying out a range of regulatory affairs duties to ensure company products are registered with worldwide regulatory bodies in a timely fashion and to ensure such licenses are maintained with the latest relevant standards.

Reporting to the Regulatory Affairs Manager the role will involve allocating the technical files for responsibility. Ensure technical files are maintained and reviewed regularly against all regulatory standards and in Q Pulse System ensure all codes are allocated to relevant technical files.

The job entails interaction between departments including new product development, Quality Assurance but also with suppliers; it is essential that the jobholder has good interpersonal and communication skills.

Knowledge / Qualifications:
Technical skills and abilities
Educated to degree or equivalent level ideally within biological sciences or related subject
Good understanding of global regulatory / QA requirements
Previous experience within Medical Devices, Pharmaceutical manufacturing or related industry.
Working knowledge of 13485 & 93/42/EEC & MDSAP
Previous experience within Quality Assurance and/or Regulatory Affairs would be a distinct advantage.
Good working knowledge of Word and Excel
Good command of spoken and written English
Attention to detail


Regulatory Affairs Officer

Life Sciences

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