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Sr. Regulatory Affairs Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 11/25/2018

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.  

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.

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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