Senior Regulatory Affairs Manager - Small expanding company - Medical Devices-Grow the division

7 days left

Location
East Midlands Region
Salary
Flexible
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
NM1398
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Regulatory Affairs & Quality Assurance Manager or Director – Medical Devices

Excellent Package, with Stock options

Full time and permanent role.

Location: Midlands / Home Based 2-3 days in office rest remote.

 

A small company with a range of very innovative products which could be massive.  Company  is NASDAQ listed. The plan is to grow big and the candidate will be pivotal to this but will also be in ‘at the start’ and so should be able to grow with the company.

Regulatory Affairs & Quality Assurance Manager or Director – Medical Devices

Excellent Package, with Stock options

Full time or contract consulting role will be considered

Location: Loughborough, UK

The Company

A public listed company Headquartered in Loughborough, Leicestershire, we are an innovative, R&D led company focussed on non-invasive and convenient medical diagnostic technologies designed to provide clinically relevant data for better management of chronic diseases and wellness and novel devices and technologies to deliver known molecules through the skin in innovative and cost-effective ways.

The Role

We seek to appoint a RA/QA Manager, which is an excellent opportunity for an experienced yet ambitious professional to join a fast paced, entrepreneurial culture in a challenging role supporting regulatory compliance across the business.

The RA/QA Manager will have responsibilities for overseeing quality and regulatory activities across the group and as such we are looking for a proactive, experienced professional who can work with and guide our product development team as well as supporting regulatory compliance for the wider group.

The main responsibilities of this role include:

  • Management of the QMS (Quality Management System)
  • Responsible for regulatory compliance for MDD, MDR and ISO 13485
  • Compile technical files for Diagnostic and Drug Delivery devices
  • Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
  • Direct liaison with Notified Bodies and Regulatory Agencies including FDA and other international agencies
  • Risk and CAPA management
  • Organizing and carrying out internal and external quality audits including supplier audits for existing and new suppliers
  • Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
  • Keep up to date with changes in regulatory legislation and guidelines together with customer practices and changes to device standards and testing in all countries where we market product.

The ideal applicant will be someone with strong medical device industry experience and up to date knowledge of quality and regulatory standards and will preferably meet all of the following:

  • An excellent first Degree and substantial post-qualification experience
  • Circa 8 (or more) years’ experience within medical devices and an understanding of MDD / MDR up to Class IIb certification including categorising change notifications.
  • Previous experience working in an ISO 9001 and 13485 accredited environment.
  • Experience with generating, maintaining and updating technical files to support submissions in Europe, US and preferably other territories
  • Extensive knowledge of US submissions and FDA requirements including 510(k), PMA and ‘De Novo’ applications
  • Experience of Notified Body and FDA audits
  • Experience in overseeing CER’s
  • Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
  • Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
  • Must be prepared to take a ‘hands on’ approach to all aspects of the quality and regulatory systems and to take on ‘ad hoc’ projects as the business requires.

Excellent career growth prospects with very attractive salary package and stock options.

 

#regulatoryaffairs#regulatoryaffairsmanager#medicaldevices#MDD#MDR#CER#regulatorycompliance#ISO13485#QMS

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