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Permanent

Regulatory Affairs Specialist - Remote Working

  • Location

    UK

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    86993

  • Contact

    Will Godfrey

  • Published

    20 days ago

Overview

This is a great opportunity for an experienced Medical Device Regulatory Specialist offering the flexibility of fully remote working.

Benefits

  • Remote Working

  • 23 days holiday + bank (3 days reserved for Christmas shutdown), rising to 29 + bank with service

  • Defined-contribution Pension Scheme - Company will match and double your contribution up to an employee contribution of 6% ( 6% employee +12% employer = 18% )

  • Free Life Assurance

  • Private Medical Insurance

  • Free Annual Health Check with BUPA

  • Access to a range of discounts and cash back offers

Job Description

The Regulatory Specialist will ensure continued compliance with all relevant regulatory requirements of both internal corporate standards and external regulations and standards issued by Competent Authorities, Notified Bodies and Certification Bodies.

This will involve the timely identification and co-ordination of regulatory changes to ensure no negative impact on the business. Including the development and review of product technical documentation such as medical device files and all related documents to demonstrate regulatory compliance to the Notified Body as well as regulatory dossiers required for submissions of registrations to the competent authorities where the company intends to market their products.

Post-Market Surveillance: ensuring continued compliance to all relevant regulatory requirements regarding timely reporting of product adverse events to Competent Authorities. Co-ordination of Field Safety Corrective Actions (FSCA) both for products where the business acts as legal manufacturer and distributor and communications with internal stakeholders, regional stakeholders and any requests raised by the Competent Authorities and Notified Bodies as a result of those actions.

Responsibilities

  • 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 business 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 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, internal policies and Global Business Rules 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).

Required Skills

  • 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, quality compliance.

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

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.