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Staff Regulatory Affairs Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 5/25/2019

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 to be based in Mahwah, NJ.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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. 
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Staff Regulatory Affairs Specialist, you will to develop regulatory strategies and ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

  • Strategize and collaborate with cross functional teams for patient-specific devices
  • Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Assist in the development of regulatory strategy and updates strategy 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 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 tools

What you need

  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
  • A minimum of 5 years of experience working in a Regulatory Affairs role.
  • Recent medical device regulatory affairs experience required.
  • Previous pre-market regulatory affairs experience required.
  • Experience with US and European medical device regulations preferred.
  • Experience with US, EU custom/customized orthopedic devices preferred.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to be self-directed, self-motivated, and able to prioritize and resolve competing demands and priorities required.
  • Experience working in a team-oriented, collaborative environment preferred.
  • Ability to meet customer requirements while managing overall expectations required.

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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