Your (new) Opportunity:
- Manage and Maintain compliance of Takeda´s Global Quality Device and Combination Products (DCP) processes and quality records through regulatory intelligence analysis of changing device and IVD regulations
- Support technical and quality systems audits and inspections by internal stakeholders, customers, notified bodies or health authorities
- Manage global complaints process through device vigilance assessments and management of clinical device complaints
- Maintenance of Device Quality metrics and KPIs and ensuring escalation of trends as required
- Coordination, front and backroom support for all device related audits and inspections as well as any required follow-up
- Coordination and compilation of device management review as well tracking of all actions and commitments
- Coordination and review of vigilance for all complaints related to a device, IVD or combination product
Your Skills and Qualifications:
- Bachelor’s Degree in Science, Engineering or equivalent technical discipline
- At least 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 2 years Quality Assurance and/or Quality Compliance roles
- Good understanding of EU, US and international medical device and combination products regulations and standards including but not limited to Part 4, CFR 820, 803, ISO 13485, MDSAP, ISO 14971, E.U. Medical Device and In-Vitro Diagnostic Regulation
- Experience with Class I & II & III sterile and non-sterile medical devices
- Written and oral fluency in English
- Knowledge of regulations for device and combination products including but not limited to 21 CFR Part 3, 4 & 820 as well as MDR 2017/745 and ISO 13485
- Experience preparing for and supporting notified body audits and other health authority inspections
- Strong technical expertise to ensure robust analysis of product data and the ability to use that information to make scientifically sound Quality risk-based recommendations and decisions.
- Strong decision making skills
- Ability to assess information and determine the critical issues that need to be escalated
- Acumen to handle complex situations and multiple responsibilities
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4 527,78 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
AUT - Wien - Industriestrasse 67