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Senior Manager - Medical Device Professional, Third Party Operations Quality Europe

Date: Mar 25, 2021

Location: Sofia, BG, 1407

Company: Teva Pharmaceuticals

Company Info

 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

In  August 2016 Actavis has been acquired by Teva Pharmaceutical. In Bulgaria we are the largest employer in the pharmaceutical industry with near 1700 employees in the two manufacturing plants (Dupnitsa and Troyan); sales and marketing organization and in a number of global corporate functions based in our country. As a Teva company, in October 2020 Actavis has started the process of re-branding and anticipating the Teva brand.

 

We are looking for qualified and motivated candidate for the role of Senior Manager - Medical Device Professional, Third Party Operations Quality Europe, based in Sofia.
 

Main Responsibilities

 

•    Actively participates in projects to implement the Medical Devices Regulation (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 Contract Manufacturing Organizations 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 Standard Operating Procedures to identify and eliminate gaps in policies
•    Develop, recommend and monitor corrective and preventive actions (CAPA) and CAPA effectiveness reviews
 

Main Requirements

 

•    Bachelor’s degree in Science or Engineering with a minimum of five 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
 

We Offer

 

•    Dynamic and challenging work environment in one of the world leading pharmaceutical company 
•    Competitive remuneration bound with performance
•    Additional healthcare insurance
•    Transportation allowance
•    Flexible working hours and option to work from home as per the company policy
•    Opportunity for development

 

If this sounds like the right opportunity for you, send us your CV in English
Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.
 

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.