Product Specialist / Product Expert / QMS Auditor / Regulatory Auditor

Location: Bavaria-Area, Germany.

Type: Permanent Full Time.

Salary guideline: Negotiable depending on experience.

Business Travel: Yes, approx. 35%.

Product Type and Experience: Active or Non Active Medical Devices and "min. 4 years expertise".

Purpose: Technical File Reviews and QMS Assessment.

The position:

Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.

Auditing (to limited extent): Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, MDR), MDSAP / Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485).

Project Management: Provide project management for customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.

- Conscientious assessment of quality management systems and technical documentation during announced and unannounced audits.

- Inspections at manufacturers of active or non active medical devices according to EU guidelines and quality management standards according to the specifications of other regulatory systems.

- Continuous support of evaluation and certification projects including preparation of the corresponding documentation and communication with customers.

- Dedicated collaboration and independent project work in the context of supporting national and international customers.

Education/Qualifications:

Minimum Degree Qualified - hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.

Three / Four years minimum work experience in design / product development / manufacturing engineering one of the following medical device product categories: Active Implantable Medical Devices, Acitve Devices, Non-Active devices, Orthopedics, Cardiovascular Products, Functional Safety and Software

A relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience

Sound knowledge in regulatory requirements, e. g. MDD (93/42/EEC) and other related requirements

Sound knowledge in product-, technology- quality- or other related standards

Orientation towards the safety and performance of medical devices

Auditor according to ISO 13485 and MDD / AIMDD and CMDCAS and JGMP (a plus)

Sound knowledge in product-, technology- quality- or other related standards

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