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Job Details


Stryker

Principal Regulatory Affairs Specialist (Remote) (R447353)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Mahwah, New Jersey, United States

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com


We are currently seeking a Principal Regulatory Specialist to join our Joint Replacement Division to be based remotely anywhere in the United States.

Who we want

  • 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.

  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision..

What you will do

As a Principal Regulatory Affairs Specialist, you will be a recognized divisional expert in the regulatory affairs matters. You will work with high level of autonomy to bring new medical devices to market and support Stryker’s Joint Replacement portfolio new product development for both US and OUS Global Regulatory release. You will operate in a fast-paced environment and you will liaise with internal and external customers and establish strong relationships with Health Authorities. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You will provide leadership and guidance to junior Regulatory Affairs professionals.

  • Possess and apply comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.

  • Assess links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy

  • Provide expert strategic input and technical guidance on global regulatory requirements to new product development teams

  • Evaluate medical device regulations and determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities for bringing products to market.

  • Provide guidance to integrate regulatory considerations into global product entry and exit strategy

  • Participate in New Product Development teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.

  • Demonstrate developing technical leadership skills interdepartmentally.

  • Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.

  • Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.

  • Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes

  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

  • Monitor the progress of the regulatory authority review process through appropriate communications with the agency

  • Assess all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develop solutions to address anticipated obstacles

  • Critically assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations

  • Negotiate with regulatory authorities on complex issues throughout the product lifecycle

  • Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures

  • Develop and manage programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

  • Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions

  • Provide regulatory guidance on strategy for proposed product claims/labeling

  • Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims

  • Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions

  • Lead key negotiations and interactions with regulatory authorities during all stages of the development and review process

  • Participate in advocacy activities of a more advanced strategic nature

What you need

  • A Bachelor’s Degree in Engineering, Biological/Physical Science or equivalent focus is required.

  • A minimum of 9 years of experience in an FDA regulated industry required.

  • A minimum of 7 years of Regulatory Affairs experience required.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

  • Proven ability to develop, author and implement global regulatory strategies for new products.

  • General understanding of product development process and design control.

  • General understanding of regulations applicable to the conduct of clinical trials.

  • Thorough understanding of FDA, Europe, and international medical device regulations.

  • Previous experience with Class II/III medical devices preferred.

  • Experience authoring regulatory submissions for product approval required.

  • Experience interacting with regulatory agencies preferred.

  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.

  • Excellent analytical and writing skills.

  • Excellent interpersonal, written, and oral communication skills.

  • Effective organizational skills.

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

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