Senior Regulatory Affairs Specialist

Full Job Description

18 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.