Senior / Lead Regulatory Affairs Specialist (M/F/d)

vor 6 Monaten

Freiberg, Deutschland Stryker Corporation Vollzeit

As the **Senior Regulatory Affairs Specialist (M/F/d),** your role involves collaborating on Stryker's **Spine** **portfolio for Global Regulatory release. This entails contributing to the development and updating of regulatory strategy based on regulatory changes. You will play a key role in supporting the product lifecycle through obsolescence, assessing changes made to the device post-launch to determine the regulatory impact on the current clearance.

Additionally, you will actively participate in cross-functional teams, formulate global regulatory strategies, author regulatory submissions, engage with regulatory agencies/notified bodies. This position is integral to supporting the Spine product portfolio, Spine navigation solution utilizing advanced software aimed at enhancing patient outcomes.

**What will you do**
- As the Senior Regulatory Affairs Specialist, you will assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- You will provide regulatory information and guidance for product development/ enhancement and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- You will develop regulatory strategy and update strategy based upon regulatory and product changes
- You will evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
- You will perform regulatory impact assessment of post-market changes with no supervision.
- You will identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
- You will determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

**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 2 years’ experience in medical technology or another regulated sector in the area of quality or regulatory affairs. Medical Device regulatory affairs experience is preferred.
- You already have experienced working with ISO 13485 and 21 CFR 820 compliance
- Your English and German language(preferred) skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.

**Additional information**

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site at our location in Freiburg should be always given 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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