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Senior Manager - Medical Device Professional, TPO Quality Europe (m/f)

Date: Mar 25, 2021

Location: Amsterdam, NL, 1098

Company: Teva Pharmaceuticals

Our company

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Your responsibilities

  • Actively participates in projects to implement the MDR requirements for in-house-manufactured and third party produced substance-based Medical Devices as well as TPO-related devices co-packaged with medicinal products and Combination Products where the device and the medicinal product form a single integral product.
  • Actively participates in projects to implement Unique Device Identification (UDI) System for in-house-manufactured and third party produced substance-based Medical Devices (class III, IIb, IIa, Is, I devices)
  • Coordinate/negotiate Quality Agreements with CMO’s considering the specific MDR requirements for TPO-related devices co-packaged with medicinal products and Combination Products where the device and the medicinal product form a single integral product.
  • Support the MDR upgrade of Medical Device Technical Documentations.
  • Support the Quality Management System (QMS) for substance-based Medical Devices as well as the QMS for TPO-related products (risk management, change control, deviation, complaints, CAPAs, supplier qualification, post-market surveillance, vigilance etc.)
  • Evaluate Medical Device Standards and Regulations against local SOPs to identify and eliminate gaps in policies. Develop, recommend and monitor corrective and preventive actions (CAPA) and CAPA effectiveness reviews. 

Your profile

  • Bachelor’s degree in Science or Engineering with a minimum of five (5) years’ experience in the Medical Device or Combination Products field.
  • Must have working knowledge of EU Medical Device Directive 93/42/EEC (MDD) and the subsequent EU Medical Device Regulation 2017/745 (MDR).
  • Knowledge of ISO13485 & ISO14971 Standards, and experience with applicable international regulations/guidelines is highly desirable.
  • Experience with substance-based medical devices or other devices, syringes, auto-injectors, nasal sprays, and transdermal patches all desired
  • Experience with elements of Quality Management Systems such as risk management, change control, deviation, complaints, CAPAs, supplier qualification, post-market surveillance and documentation management systems, SAP, as well as participation in Quality Councils and Management Review.
  • Excellent organizational and interpersonal skills
  • Experience in project management
  • Strong computer skills (MS Office, SAP and TrackWise) are desired.
  • Fluent English skills both written and spoken

Function

Quality

Reports To

Associate Director Third Party Operations Quality EMEA Medical Devices, Cosmetics & Food Supplements

Pre-Employment Screening

Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.