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Director Regulatory Affairs and Quality Assurance EMEA & India

Location: Crawley Salary: £80000 - £90000 per annum
Sector: Medical Devices Type: Permanent
Contact: Matt Henocq Job Published: 24 days ago

Director Regulatory Affairs & Quality Assurance EMEA & India

Description

The Director Regulatory Affairs & Quality Assurance EMEA & India is a senior management position responsible for the strategic and tactical management of the Regulatory Affairs & Quality Assurance EMEA & India groups and the continuous learning program for Global Regulatory Affairs.

RESPONSIBILITIES

  • Drives activities with a sense of the overall mission
  • Actively participates in defining the vision for the department
  • Set organization goals, in collaboration with partner organizations and managers
  • Define the direction of change
  • Commits to Quality - Adheres to and improves processes and work
  • Drives change - Identifies, plans, and implements changes
  • Demonstrates integrity - Positive relationships and honest dependable results
  • Provides creative solutions - Offers proposals and ideas to solve problems
  • Regional Coordinator for Regulatory Submissions and Regulatory Strategies. Inform local organizations about changes in legislations, support local organizations with interpretation of legislations and advice about strategies.
  • Support, create and maintain the Regional Submission Process(s) and Regulatory Roadmap.
  • Manage and coordinate the Regional Submission Area.
  • Be my client's representative in the region in interactions with international bodies in the field of regulatory submissions with a potential to have an impact on the business,
  • Participate/report to management review regarding all of my client's regulatory submissions and quality system.
  • Support locally appointed regulatory and quality staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.
  • Issue and change processes and procedures.
  • Deploys and implements my client's Quality Policy and other directives and processes as applicable to the region.

RELEVANT KNOWLEDGE, SKILLS AND COMPETENCIES

  • Experienced manager and leader, able to demonstrate excellent communication and interpersonal skills.
  • Professional integrity with an ability to lead the interpretation of product regulation and translate into meaningful business requirements.
  • Objective driven and customer focused, with an ability to influence people.
  • Capable of leading teams to deliver desired results.
  • A structured approach to problem solving with an appreciation of quality tools & techniques.
  • An effective team player who can mentor and lead problem solving to provide solutions to the business.
  • Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
  • A positive attitude towards change to promote the global goals of the business.
  • Knowledge and proven track record in Regulatory Affairs for Medical Devices.
  • Knowledge of region regulations.
  • Knowledge in either Supplier Quality, Quality or Manufacturing Engineering, gained preferably within a medical device environment.
  • Preferably an experienced ISO Auditor
  • Knowledge of the European Directive for Medical Devices and US FDA regulations would be an advantage.
  • Proficient in Microsoft Office applications
  • Degree equivalent in an engineering related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
  • Able to work within a multi-cultural environment.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.

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