Regulatory Affairs Specialist, Medical Devices Yorkshire

Regulatory Affairs Specialist, Medical Devices

Location: North Yorkshire

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

Salary: GBP40,000 - GBP45,000 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)

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 etcImportant Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h u s s e l l - t a y l o r . c o . u k