RA Manager

RA Manager

Biotechnology

Location Newcastle Upon Tyne

Salary £40,000 to £60,000

Contract Permanent

Reference RAHB1822

Date Posted

Consultant

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1 week left to apply


RA Manager | Competitive | Newcastle Upon Tyne, UK

This prestigious, leading, and well-established medical diagnostic company comprises two flagship business divisions that specialise in the design, manufacture and continued support of Haemostasis systems and Clinical Electrophoresis equipment.

The Regulatory Affairs Manager will ensure the company meets IVDR, IVDD compliance and ISO 13485 standard. The RA Manager will also manage all global registration related activities, including producing country specific documents where required and acting as signatory on behalf of the company.

Key Responsibilities:
1. To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use.
2. To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
3. To assist with the maintenance of the site Quality Management System
4. To manage all Safety Data Sheets (MSDS) and associated documentation and advise on Dangerous Goods Transport.
5. To maintain license requirements with the Home Office.
6. Register new products and/or significant changes with relevant regulatory authorities
7. Assess the impact of design changes for regulatory compliance and the implications for maintaining product registration.
8. To work with the marketing and technical research teams to define product positioning and develop compliant marketing materials.
9. To maintain high levels of integrity and regulatory compliance and ensure the company is Audit ready at all times.

Key Skill Required
1. At least 2 years’ experience in medical device or pharmaceutical regulatory affairs management.
2. Knowledge and experience of Quality Management Systems e.g. ISO 13485
3. Knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
4. Sound working knowledge of Good Manufacturing Practices, including personnel training skills.
5. Design and preparation of Standard Operating Procedures.
6. Review and approval of compliance of company production and QC documentation.
7. Clear attention to detail with regards existing and new documentation.

If you like the look of this role but you’re hesitant to apply because you don’t meet all of the necessary skills, then I’ll encourage you to apply anyway. We’re looking for someone to grow and learn on the job, which can’t really happen if you already know everything.

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RA Manager

Biotechnology

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