Senior Regulatory Affairs Specialist ensuring compliance with worldwide regulatory requirements at Argen. Responsible for developing regulatory strategies, submitting filings, and leading compliance activities.
About the role
- Principal Regulatory Affairs Specialist supporting regulatory lifecycle for orthopedic implants and instruments. Assessing trends and developing regulatory strategies at Stryker's Trauma & Extremities Division.
Responsibilities
- 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
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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