Principal Regulatory Affairs Specialist
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Columbia City • 🇺🇸 United States
Visit company websiteJob Level
Lead
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory pathways evaluationregulatory submissions reviewclinical data assessmenteCTD submission processesSOP developmentstrategic regulatory planningcompliance training programsnegotiation with regulatory authoritiesimpact analysis of regulations
Soft skills
strategic vision articulationpersuasive negotiationconstructive disagreement resolutionrelationship managementcross-functional team leadershiptechnical guidancestakeholder engagementcommunication skillscollaborative planningproblem-solving
Certifications
RAC certification