Sr. Regulatory Affairs Specialist - 30911BR - EN in Mahwah, NJ at Stryker Corporation

Date Posted: 5/31/2018

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.
Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
Achievers. Thrives on accomplishing tasks and constantly driven to do more.
Collaborators. Collaborates and builds relationships with internal and external stakeholders.
Communicators. Articulates well and expresses ideas effectively.
Learners. Great desire to learn and looks to continuously improve.
Teammates. Supports, encourages, and inspires others.

What you will do

We are looking for a collaborative team player who is interested in bringing and sustaining products on the market via pre-market submission activities with global Health Authorities. Operating in a fast paced environment, the Senior Regulatory Affairs Specialist will liaise with internal and external customers and establish strong relationships with Health Authorities. You are able to translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You are self-directed and motivated to act while taking on projects of greater complexity under limited supervision. You will provide leadership and guidance to junior Regulatory Affairs professionals.

Job Requirements

What you need
  • Bachelor’s Degree in Science, Engineering, Legal or Regulatory.
  • 3+ years experience within medical device or other regulated industry.
  • Advanced degree and/or RAC(s) highly preferred.
  • 510(k), IDE, PMA, CE Technical File/Design Dossier preparation, review, and submission experience.
  • Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents.
  • Experience with additional international regulations preferred.

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