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Director Regulatory Affairs & Quality Assurance EMEA & India: Elekta

Employer
Manor Royal Business District
Location
Crawley, West Sussex
Salary
Competitive
Closing date
19 Nov 2021

View more

Sector
Healthcare
Function
Management , Quality Management
Contract Type
Permanent
Hours
Full Time

Job Details

Elekta

Director Regulatory Affairs & Quality Assurance EMEA & India

Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

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
  • Demonstrates leadership through:
    • Delivers results
    • Aligns priorities
    • Develops teams
    • Manages change
  • 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 Elekta’s representative in the region in interactions with international bodies in the field of regulatory submissions with a potential to have an impact on Elekta’s businesses,
  • Participate/report to management review regarding all Elekta 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 Elekta Quality Policy and other directives and processes as applicable to the region.

AUTHORITIES

  • Execution of global & local RA and QA strategies and policies as defined in the departmental business plan.
  • Approve requests for function expenses incurred at a local level within the business guidelines.
  • To blockade any necessary devices that do not possess the adequate regulatory status required for shipment.
  • Authorisation of absence, sickness and holidays for direct reports
  • Performing GPMs and setting of development plans for direct reports
  • The Manager will be asked to authorize documents and forms whilst carrying out their responsibilities.
  • Sign off and release of regulatory documentation to governing agencies
  • Approves changes to the quality management system under their responsibility.
  • Manage departmental budgets as applicable.
  • Deputise for direct manager

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.

ADDITIONAL LOCAL INFORMATION OR N/A

  • Availability for international travel required

Company

Manor Royal Business District is the biggest business park of the Gatwick Diamond area and one of the south east's premier mixed activity employment hubs.

Enviable location and connections

Situated at the heart of the Gatwick Diamond on the Sussex and Surrey county borders, just two miles from London Gatwick Airport, a major motorway junction (M23 Junctoion 10) and two mainline railway stations (Gatwick Airport and Three Bridges), Manor Royal is a popular choice for a diverse range of occupiers including a host of blue chip global brands.

Manor Royal in numbers

  • One of the biggest business parks in the South East.
  • Covers an area of 539 acres – that’s over 300 football pitches.
  • 700 properties
  • 500 businesses
  • 30,000 people

Manor Royal more than a number

Since the formation of the Manor Royal Business Group (MRBG), an association of Manor Royal based business and firms, being on Manor Royal means being part of something. You’re never just a number.

Manor Royal makes sense

Scale, diversity, location and great connectivity with a property offer to match means Manor Royal based firms are never far away from their suppliers, customers and a talented workforce.

Pay us a visit

Visit www.manorroyal.org to find out more and to get in touch

 

Company info
Website
Mini-site
Manor Royal Business District
Location
7 Magellan Terrace (Ground Floor)
Gatwick Road
Crawley
West Sussex
RH10 9PJ
United Kingdom

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