Senior International Regulatory Affairs Specialist - 28057BR - EN in Cary, IL at Stryker Corporation

Date Posted: 2/14/2018

Job Snapshot

Job Description

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Achiever. Strong work ethic with a “leads by example” mindset.
Deliberative. Good judgement with ability to identify risks and make sound decisions.
Learner. Demonstrated commitment to learning and the ability to transfer knowledge, ideas and concepts.
Collaborate. Builds and maintains relationships cross functionally as well as externally to create opportunities.
Communicator. Articulates well and expresses ideas effectively.

What you will do

As a Senior International Regulatory Affairs Specialist, you will provide solutions adapted to the global market. With a diverse portfolio of products that includes pharmaceuticals, medical devices, and cosmetics, this role will play a critical part in our continued global growth plan.

In this role, you will be responsible, but not limited to the following:
  • Evaluate, prepare, and submit global registration applications with a focus on timeliness and follow-through to ensure a positive outcome.
  • Serve as a resource to broader RA team as well as working closely with marketing, sales, engineering, product development and quality.
  • Manage projects with an emphasis on strong communication and coordination.
  • Provide strategic guidance on global regulatory submissions.

Job Requirements

What you need
  • BS in Engineering, Science or related. MS or RAC(s) preferred.
  • A minimum of 3 years’ experience in Regulatory Affairs.
  • Must have pharmaceutical, medical device, or cosmetic experience within international markets. Preference for pharmaceutical experience.
  • Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions is required.