Senior Regulatory Affairs Specialist

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

!2 month contract with full Stryker benefits

As a Senior Regulatory Affairs Specialist you will join a driven and experienced team of Regulatory professionals to support regulatory activities focusing on Product Transfer Project.

What will you do

• As a Senior Regulatory Affairs Specialist 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, Freiburg and SGTC 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 QMS updates as well as other projects such as the implementation of the EU MDR 2017/745 or the UK MDR.

What will you need

• You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred (level 8)

• You have gained a minimum of 2 years’ experience in medical technology or another regulated sector in the area of quality or regulatory affairs and ideally have experience in regulatory assessment of post-launch design, regulatory and production changes.

• You have already acquired knowledge of the EU MDR 2017/745, MDCG 2020-3, NBOG 2014-3 and / or the FDA requirements for assessing post-launch design, regulatory and production changes.

Additional information
The position is initially limited to 12 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. 

Your application
We are looking forward to your online application including all relevant documents such as CV, cover letter, transcript of results, and references. Please note to upload all attachments directly in our application procedure under the item "CV". 

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

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com