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Principal Project Manager, Regulatory Affairs in Mahwah, NJ at Stryker Corporation

Date Posted: 5/24/2019

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 Principal Project Manager, Regulatory Affairs to join our Joint Replacement division to be located 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.
  • Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
  • Collaborators. Collaborates and builds relationships with internal and external stakeholders.
  • Teammates. Supports, encourages, and inspires others.
  • Communicators. Articulates well and expresses ideas effectively.

What you will do

As the Principal Project Manager, Regulatory Affairs, you will manage the regulatory deliverables, including cross-functional support items, related to the evolving European Union requirements as part of the new EU Medical Device Regulation. You will assist with strategies and execution of regulatory plans related to legacy products and new product development specific to EU premarket submissions (Design Dossiers and Technical Files). In addition, you will become a valuable contribution to the generation of documents/procedures to gain EU MDR compliance and long-term sustainability and growth of Stryker products in the European Union market.

  • Facilitate full compliance for multiple products with the new European Union Medical Device Regulation (EU MDR)
  • Work as the recognized expert, managing large projects or processes, with responsibilities that include working with other functional areas to identify, modify, or create necessary documentation to meet the EU MDR
  • Lead cross-functional team to execute technical documentation in compliance with the applicable regulatory requirements and generating submissions as needed
  • Establish regulatory deliverables and plans for the projects assigned. Track the execution of the projects and develop dashboards and reports for communication across the organization
  • Ensure overall compliance and manage remediation efforts of technical documentation
  • Drive the preparation, quality control, and delivery of technical documentation required for full compliance with the EU MDR and associated submissions.
  • Manage global regulatory strategies and impact assessments of changes that may impact regulatory approvals
  • Collaborate with global regulatory teams to ensure that products remain compliant around the world

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline.
  • Advanced degree preferred, PMP and/or RAC certification preferred.
  • A minimum of 8 years of experience within an FDA regulated industry.
  • A minimum of 2 years of demonstrated experience managing projects in at least one discipline (RA, QA, R&D, Operations, etc.).
  • A minimum of 4 years working in or with regulatory affairs and general understanding in regulatory affairs.
  • Knowledge of EU regulatory requirements including the MDD and MDR for medical devices preferred.
  • Ability to choose the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources.
  • Ability to navigate the dynamics, alliances, and competing requirements of the organization or business.
  • Willingly accept challenging assignments and new career opportunities that stretch and build capabilities
  • Demonstrated versatility and a willingness to manage and lead a team through change and ambiguity.
  • Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills.
  • Ability to build trusting relationships with all levels of management and presenting proposals to executives.
  • Ability to generate and explain opportunity analysis and value assessments accurately.
  • Demonstrated ability to mentor, train, and develop direct and indirect team members.

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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