|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
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.
- 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.