Regulatory Affairs Specialist (R&D) - Focus: Technical Documentation (m/f/d)
We are looking for an experienced Regulatory Affairs Specialist (R&D) / Technical Documentation for our R&D Regulatory Affairs Department here at the Augsburg R&D Center of PENTAX Medical. We are the innovation hub for Pentax Medical, a globally operating manufacturer of medical endoscopic systems, and we are looking for an open-minded and innovative new colleague. Together, we'll encounter the challenges of developing the Technical Documentation of medical endoscopes and systems. Our results can have a direct impact on patient care by avoiding or curing diseases such as cancer - globally.
You will play an important role in the collaboration and development of the technical documentation in the area of research and development for the future endoscopic systems of Pentax Medical. Your main task is to support R&D in preparing the necessary technical documentation for the medical devices to be developed according to the state of the art in order to approve them for the market. In addition, you will be responsible for coordinating risk management activities and supporting the development team in all regulatory matters.
Your tasks
* Coordinate, create, review and maintain technical documentation in accordance with global and internal R&D processes and relevant medical device requirements in collaboration with the development team
* Coordinating, documenting and maintaining risk management files in collaboration with the development team
* Support R&D in defining and establishing requirements (e.g. regulatory requirements, user requirements, system requirements, etc.)
* Support global R&D in defining regulatory strategies
* Support R&D in verification and validation activities
* Ensuring compliance with regulatory requirements in accordance with EN 13485:2021, MDR 2017/745, 21 CFR 820
* Ensuring that the R&D department knows and applies the current standards, regulations and all necessary procedures and templates
* Interaction with the R&D RA team of the legal manufacturer (Hoya Cooperation) and Pentax Medical
Your qualifications
* A degree with a scientific background, e.g. medical technology or a comparable qualification
* Professional experience in dealing with regulatory requirements of medical devices
* Knowledge and practical experience in risk management activities and methods like FMEA and FTA
* Knowledge and practical experience with the main standards and regulations for medical devices (e.g. MDR, ISO 13485, IEC60601-1, ISO 14971, IEC 62366-1, IEC 62304)
* Knowledge about US FDA regulations/requirements preferable
Abilities
* Be able to work in a multi-disciplinary, multi-cultural and multi-language team
* Ability to work simultaneously in different projects
* Cooperative way of working with high degree of independence, solution-oriented and self-motivation
* Strong quality awareness and technical understanding
* Language: Very good knowledge of German and English
What awaits you
* Be at the forefront of medical device development
* Shaping the future of endoscopy
* Your work can have a global impact
* Open team culture and a welcoming work place
* Working in a multi-disciplinary and innovative team
* Dynamic team with short ways
* Direct contact with high grade medical professional
* Part of a global organization
What we offer
* Permanent contract
* High degree of responsibility and impact
* Flexible work hours
* Possibility for home office
* Free drinks and coffee
* Subsidized Deutschland ticket
* Jobrad
* Company voucher program for different shops
* Company parties and events
* Support with language courses for non-native speakers