Jobs

Regulatory Affairs Specialist - 6mth FTC - Southern

Medical/Pharmaceutical - Regulatory
Ref: 443 Date Posted: Wednesday 11 May 2022
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Our client is a global leader in minimally invasive medical technology solutions. Working from home you will liaise with their R&D centre of excellence in the UK.

The culture of the business has extremely strong core values which include agility, empathy, long-term view, unity, and integrity. The regulatory Affairs Consultant is as such an extremely pivotal role within the business.

You will be responsible for identifying any regulatory changes and ensuring there are no negative impacts on the business. This will include developing and reviewing technical documentation to demonstrate regulatory compliance to the Notified Body.

 

Main Accountabilities:

• Implement and work to all applicable regulatory and quality requirements as stipulated within the Quality Manual, Quality Policy, and Quality Objectives.

• Implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives.

• Generate technical documentation for both Summary of Technical Documentation (STED) for CE and UKCA certification and for international product registration purposes.

• Support and supply information as required to SBCs, distributors, Competent Authorities and Notified Bodies relating to product registration/establishment registration in any market where the client markets its products.

• Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification, UKCA and registration activities.

• Manage Engineering Change Request/ Engineering Change Order (ECR/ECO) process including notification to S-BCs of changes which are notifiable under local regulations and co-ordination of translations for those ECR where RA acts as change co-ordinator.

• Creation, maintenance and compliance with Standard Operating Procedures (SOPs), internal policies and Global Business Rules (OGBR) related to Quality Management System and their training to the relevant individuals.

• When required, provide support for assessment of Health Hazard Evaluations (HHE) and management of field safety notices and field safety corrective actions (FSN/FSCA).

 

Requirements:

• University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.

• Minimum of 2 to 5 years post qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.

• Good understanding of EU MDD/MDR, ISO 13485 and MDSAP requirements and ability to communicate and provide training on these technical and regulatory documents to a less specialist audience.

• Knowledge from a registration perspective of active medical devices, risk assessment, clinical experience, post-market surveillance and quality compliance.

• Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point).

• Some travel may be required to visit subsidiary companies and third parties.

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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