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Regulatory Affairs Specialist, Medical Devices

Vacancy Title: Regulatory Affairs Specialist, Medical Devices
Contract Type: Contract
Location: Swindon, Wiltshire
Industry:
Salary: £40000 - £45000 per annum
REF: J908391_1621504635
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Vacancy Published: 24 days ago

Vacancy Description

Regulatory Affairs Specialist, Medical Devices

Location: Swindon area, 2 to 3 days a week the rest remote

Type: Fixed Term Contract for 12 months (potential to be extended/ will be reviewed)

Salary: £40,000 - £45,000 pa

Additional: Upto 5% bonus, Pension - EE 3%, ER 6% or EE 4%, ER 8%, 4x annual salary life assurance

Cont… BUPA private medical care, canteen etc

Hours: Monday - Thursday (8.30 - 16:30), Friday (8:30 - 13:30)

Our Client, an established/global medical device company are moving their technologies (tech transfer) and production lines to HQ in Yorkshire. This project is a vital one and could lead to further progression at their main site - if the successful candidate decided they did want to stay with the company; or a further extension which would be reviewed at the end of the 12 months.

The Role:

  • Represents Regulatory Affairs on product lifecycle development teams to ensure that all regulatory requirements are met throughout the development process
  • Updates and maintains all Design History Files and associated documents
  • Completes submissions to regulatory entities as needed and maintains a tracking system for documents submitted to agencies and/or customers
  • Creates and/or maintains technical documentation as required according to customer specified requirements
  • Documents regulatory strategy and impact assessments for new product introductions and changes to existing products and/or manufacturing facilities/processes.
  • Maintains regulatory files/database and chronologies in order
  • Supports the sites in the timely renewal of certificates, licenses, and registrations
  • Assists in creation and approval of product labelling, TDS, MSDS, and instructions for use (IFU) meeting applicable regulatory and customer-specified requirements
  • Reviews and provides regulatory oversight for marketing literature for compliance with relevant regulatory requirements
  • Provides the regulatory review of customer complaints and determines, in collaboration with customers, if regulatory reporting is necessary in post market surveillance activities
  • By utilizing regulatory knowledge and expertise, provides support and expansion of the Regulatory Services function as part of the Product Life Cycle Management (PLM) process to customers
  • Maintains current knowledge of MDD, MDR, FDA and international regulations with guidance and standards applicable to Client HC products
  • Participates in research of regulatory issues and dissemination of regulatory information to Production, QA, QC, R&D department, and Senior Quality Management
  • Executes compliance GAP audits with remediation plans at EU sites as required
  • Supports the acquisition and reporting of monthly regulatory quality metrics and KPIs.
  • Performs other activities as required

The Person:

  • Will hold a Degree in a Scientific discipline (or similar)
  • Will have strong regulatory affairs working knowledge and experience with QMS regulations Medical Device Regulation (MDR and US FDA regulatory requirements
  • and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive (MDD),
  • Demonstrated experience interfacing with external Regulatory inspectors/auditors and customer auditors
  • Will have experience in Class I/II Medical Devices
  • Will ideally be a lead auditor with Lean qualifications (desirable); FDA 510K Submissions etc

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