TECHNICAL LEADER - MEDICAL DEVICES - CHINA / APAC Region

TECHNICAL LEADER / MANAGER – CHINA – MEDICAL DEVICES

Job Title: Team Lead / Manager.

Division: Medical Device Operations, region APAC.

Reports to: Director, Medical Device Operations and Delivery.

Location: APAC (China / Japan).

Salary: Negotiable plus 25% bonus.

Type: Permanent.

Purpose of Position:

• Lead the specific Notified Body Team.


• Manage a portfolio CE marking schemes focused around your competence


• Deliver technical reviews, audits and external training in support of the CE marking schemes


• Act as “Technical Sales” support to the commercial team as appropriate


• Ensure one globally harmonized way of working, competence level and service delivery


• Provide leadership and mentoring in areas of competence for Operations and technical teams.


• Build and drive the output of the technical team


• Deliver CE Marking technical review, scheme management, audit and training services for device manufacturers in your sphere of competence


• Provide expert leadership on Technology across NBs and provide Certification Decision Panel support


• Support the Commercial Team by responding in a timely fashion to quote requests


• Provide advice and support to product specialists and scheme managers on certifications in your area of expertise that may have a regulatory challenge


• Delivery of all services to time and quality, with positive feedback from clients and colleagues


• Delivering budgeted business targets for your team


• Thorough, prompt reporting back from meetings with third parties and effective handling of issues that arise


• Personal growth in chosen area of expertise and business development support


• Thorough knowledge of IVD / Medical Device regulations


• Concepts and intent of Product Certification and service orientation


• Knowledge of business processes and the application of quality management standards


• Demonstrable people management and leadership skills


• Conceptual and analytical thinking, efficiency and results orientation


• A team player good at relationship building internally and externally, and work independently


• Broad technical understanding of client industry products


• Degree in discipline relevant to IVD or Medical Device manufacture, or equivalent qualification, preferably in the area of chemistry, material science, biology or similar


• Relevant experience in industry related to the design and development of IVDs or medical devices

Key Responsibilities & Accountabilities:Knowledge / Skills / Abilities:Educational qualifications

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