Staff Regulatory Affairs Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 6/24/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Affairs Specialist to join our Joint Replacement Division based in Mahwah, NJ.

Who we want

  • Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 
  • 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 primarily focused on the European Union (EU). Operating in a fast-paced environment, as the Staff Regulatory Affairs Specialist you will liaise with internal and external customers and establish strong relationships with Stryker’s Notified Bodies to enable long term growth in the EU marketplace in the facing of the changing regulatory environment under the new EU Medical Device Regulations. 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.

  • Strategize and implement necessary changes to internal processes to address EU MDR requirements
  • Develop and execute processes to maintain compliance of assigned design dossiers
  • Collaborate with cross functional teams to secure EU MDR support documentation
  • Assist in the development of regulatory strategy and updates based upon regulatory changes
  • Evaluate proposed products for regulatory classification and jurisdiction
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines
  • Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Assist other departments in the development of SOPs to ensure regulatory compliance
  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Provide regulatory information and guidance for proposed product claims/labeling
  • Monitor the progress of the notified body/regulatory authority review process through appropriate communications with the agency
  • Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tool

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline.
  • A minimum of 5 years of experience in regulated industry (medical devices, pharmaceuticals, or biologics preferred).
  • Previous experience supporting global submissions including European Union submission experience required.
  • A minimum of 2 years of Regulatory Affairs experience required.
  • Ability to negotiate internally and externally with global Health Authorities including EU Notified Bodies required.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Ability to understand and explain detailed regulatory positions and strategies.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to communicate and network with regulatory and cross-functional personnel to obtain relevant information.
  • Excellent analytical and writing skills.
  • Strong interpersonal, written and oral communication skills​.

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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