Regulatory Affairs Specialist
About The Position
Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals. In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways and strategies. Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met. Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators. Participate in the development, review, and substantiation of product labeling and claims. Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.
Requirements
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
- 2 years of experience in medical device regulatory affairs or quality assurance.
- Understanding of the current Regulatory environment and demonstrating the ability to perform within.
- Applied knowledge of FDA regulations and guidelines.
- Ability to evaluate information to determine compliance with standards, laws, and regulations.
- Travel required up to 5%.
Responsibilities
- Planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals.
- Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
- Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
- Communicate requirements of regulations to internal or external customers.
- Recommend regulatory pathways and strategies.
- Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.
- Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators.
- Participate in the development, review, and substantiation of product labeling and claims.
- Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.
Benefits
- competitive total rewards package
- continuing education & training
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- Employee Assistance Program
- Employee Resource Groups
- Employee Service Corp
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
