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Hybrid Principal Regulatory Affairs Specialist

at Stryker
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Posted last month

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About the role

  • Assess global trends, stakeholder concerns, and regulatory issues to inform strategy.
  • Develop and update global and regional regulatory strategies aligned with business goals.
  • Identify and evaluate regulatory pathways for new product designs and market access.
  • Analyze the impact of changing regulations on pre- and post-approval strategies.
  • Incorporate expedited regulatory strategies for products addressing serious conditions or unmet needs.
  • Negotiate with regulatory authorities throughout the product lifecycle.
  • Establish and maintain relationships with government and non-government organizations affecting market access.
  • Develop and manage regulatory procedures, SOPs, and training programs for compliance.
  • Provide strategic input and technical guidance to product development teams.
  • Evaluate clinical and manufacturing changes for regulatory filing requirements.
  • Review and assess regulatory submissions, clinical plans, and product claims.
  • Ensure clinical and nonclinical data support proposed product claims and labeling.
  • Manage electronic (eCTD) and paper registration development and submission processes.
  • Lead internal review and approval processes for regulatory submissions.
  • Prepare cross-functional teams for regulatory interactions, including advisory committees.

Requirements

  • Bachelor’s degree in engineering, Science, or related field
  • A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices.
  • A minimum of 7 years of Medical Device Regulatory Affairs experience required.
  • Preferred Master’s degree in Regulatory Science or RAC certification.
  • Experience with strategic regulatory planning and global submissions.
  • Expertise in ISO standards and regulatory frameworks for medical devices.
  • Articulates the organization's strategic vision in a manner that enables others to execute plans, tactics, and actions.
  • Leverages a well-grounded knowledge of applicable laws, regulations, and policies to develop and execute plans and programs.
  • Demonstrates the ability to build agreement and acceptance through presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements

Job title

Principal Regulatory Affairs Specialist

Job type

Full Time

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

HybridColumbia CityUnited States

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