(Senior / Staff) Regulatory Affairs Specialist

vor 7 Monaten

Freiburg, Deutschland Stryker Vollzeit

As a (Senior/Staff) Regulatory Affairs Specialist (M/F/d) at our Freiburg office, step into a dynamic role that not only demands excellence in regulatory affairs for our cutting-edge CMF business at Stryker but also offers an unparalleled learning opportunity. Harness your expertise to navigate regulatory landscapes, while immersing yourself in a culture of continuous growth and innovation, positioning you at the forefront of evolving healthcare standards and advancements.

**What will you do**
- As a (Senior/Staff) Regulatory Affairs Specialist (M/F/d) you will partner with cross-functional teams to prepare regulatory change assessments and technical documentation updates.
- You will provide input to cross-functional teams on requirements, strategies and documentation needed to maintain regulatory marketing authorizations, reviewing and approving DHF and DMR records per regulatory and quality system requirements.
- You will maintain accurate and up to date regulatory documentation and data in Stryker systems to ensure global market continuity of assigned products.
- You will participate in team meetings with colleagues based in the US, Ireland, and Freiburg teams contributing to and learning from global regulatory submission and strategy experiences.
- You will also support the Regulatory Affairs team with internal and external audits and ISO 13485 QMS requirements as well as other projects such as the implementation of the EU MDR 2017/745.

**What will you need**
- You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.
- You have gained a minimum of 1 years’ experience in medical technology or another regulated sector in the area of quality, regulatory affairs or R&D.
- Ideally you have already acquired knowledge of the ISO 13485, EU MDR 2017/745, MDCG 2020-3, NBOG 2014-3 and / or the FDA requirements for assessing post-launch design, regulatory and production changes.
- You have strong time management, coordination, and communication skills, capable of executing basic regulatory tasks, supporting technical activities, and demonstrating a proactive approach to work within a dynamic regulatory environment."
- Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office. German is a preference.

**Additional** information**

The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 2-3 days per week on site at our location in Freiburg is preferred to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title.

**Your contact**:
**About Stryker

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