Senior / Staff Regulatory Affairs Specialist

vor 6 Monaten

Berlin, Deutschland Stryker Corporation Vollzeit

As a Senior / Staff Regulatory Affairs Specialist at Stryker, you will be at the heart of groundbreaking advancements, championing the integration of software-based innovative technology in upcoming product launches for our ENT division (Ear, Nose & Throat). This role uniquely caters to individuals with a background in software and/or regulatory affairs, offering an exclusive opportunity to contribute significantly to the success of software-based product launches and influence the landscape of medical innovation at Stryker.

**What will** you **do**
- As a Senior / Staff Regulatory Affairs Specialist (M/F/d) you will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- You will participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.
- 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 identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
- You will evaluate proposed products for regulatory classification and jurisdiction.
- 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 participate in team meetings with colleagues based in the US, Ireland, Berlin and Freiburg teams contributing to and learning from global regulatory submission and strategy experiences.

**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 5 years of experience in medical technology in the area of regulatory affairs and ideally have experience of 510k, PMA (Premarket approval), software and/or drug devices.
- You have good experience in project management, writing, coordination, and execution of regulatory items.
- You have already demonstrated knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance and distribution.
- Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.

**Additional** information**

The position is initially limited to **23** 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 a minimum of 2 days a week on site at our locations (Berlin, Freiburg or Cork) 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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