International Exposure as a QARA Director
If you are looking for more responsibility and international recognition, this may be the perfect role for you.
NonStop are working in partnership with a global medical devices company who are looking for a Senior QARA Director for Europe and Asia.
The international nature of this role will give you the opportunity to travel abroad and expand your network at the same time.
Travelling will ensure this role will remain interesting and will increase your cultural exposure; developing you personally, as well as professionally.
Being a part of some of the major decisions within the company will allow you to make an impact and be a key member of the team.
GENERAL SUMMARY OF POSITION:
- Oversee EMEA/APAC region's Quality Assurance and Regulatory Affairs by directing and coordinating activities consistent with established company and management goals, objectives, Medical Devices, PPEs, ISO guidelines and policies.
- Promote the development and implementation of a region-wide culture of quality excellence and understanding of the key elements related to quality system and regulatory compliance requirements, in accordance with Corporate objectives
- Oversee the strategic direction, preparation and progress of regulatory agency and notified body submissions
- Organize and lead the knowledge construction of existing and emerging regulations, standards, or guidance documents.
Interpret regulatory rules or rule changes and ensure that they are communicated throughout corporate policies and procedures
- Serve as a management representative for regulatory agency, notified body and customer audits.
- Act as the senior QARA point person for the Regional Management team on the Regulatory requirements for medical devices and PPEs, and provides guidance and action plans on desired best-in class QA practices for the EMEA-APAC Region.
- Work in close relationship with the Americas QARA Senior Director to achieve harmonized QA processes and where applicable and relevant, common and shared regulatory strategies
RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
- Responsible for driving quality excellence throughout the EMEA-APAC organization by providing overall strategic direction and guidance for the quality system and regulatory activities.
- Responsible for overall management of existing and future Quality and Regulatory practices, procedures and teams to achieve desired outcomes (registrations, new offices ISO and/or local certification, QMS rationalization) with optimal quality, efficiency and cost-effective approach
- Define a well-balanced lobbying approach within relevant MD and/or PPE organizations, including but not limited to EC MedTech, KOSHA (examples only) with objective to promote data-driven education and awareness within the international regulatory bodies.
- Ultimate decision maker to ensure that all company products meet applicable quality & regulatory standards in the market of sale.
- Ensure that clinical evidence to support product registration and marketing claims relating to individual products is of the required standard.
- Participate as a member of EMEA-APAC Executive Leadership team.
- Develop strategies, KPI's and written business policies aligned with organizational goals and regulations
Master's Degree in Engineering, Science, Technology or related field
- 10-15 years of QA and RA management experience in medical device and PPE manufacturing industry with 5 years in senior leadership position.
- Audit Management
- Business Transformation Programs support
- People management responsibility (10 FTEs or more)
Knowledge and Skills
- ISO 13485 & ISO 9001 Audits, Vigilance Reporting, CE Markings
- Product Registration, including Medical Devices and PPE (Including EMEA, Japan /China/ Canada/ Singapore etc.) FDA 510 K, REACH Regulation, Risk management ISO 14971, 21 CFR 820.20 (optional),
- Due Diligence, CAPA Management, Lean Six Sigma, Quality Auditing, 21 CFR Part 11, Quality Management, Technical Documentation, Design Control, GMP.
- Quality Management Systems (implementation, harmonization of all QMS on European level)
- Advanced computer proficiently with MS Office and solid experience working with ERP and eQMS software (eg; Trackwise)
- Quality Audit training.
- Fluent English is a necessity and fluent French, Flemish, Dutch or German would be looked upon very favorably
Desirable Job Competencies
- Strong leadership skills with the capability to motivate teams and achieve results
- Customer Focus
- Organization Agility (ability to cope with rapid change)
- Command skills
- Problem Solving combined with good Presentation Skills
- Technical Learning
- Comfort around Senior Management (Executive levels)
- Conflict Management
- Peer Relationships
- Personal Learning
- Integrity and Trust
- Additional Requirements (travel, etc.)
- Ability to travel internationally (up to 40%)
If you belive this is the right role for you, please send in your CV, in word format, to Kai Bokth at firstname.lastname@example.org or contact him via LinkedIn (https://www.linkedin.com/in/kaiyum-b-2a202914a/ ) for more information.
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