The Regulatory Affairs Manager will provide regulatory input to product lifecycle planning for respiratory health products. This role will assist in the development of multi-country regulatory strategy and update strategy based on regulatory changes; utilize technical regulatory skills to propose strategies on complex issues. The Regulatory Affairs manager will work with cross functional teams across a variety of disciplines. Must have a proven track record of achieving 510(k) clearances along with implementing the tenets of regulatory requirements within the business.
Determine submission and approval requirements
Identify emerging issues
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies and update internal stakeholders
Monitor applications under 510 (k) regulatory review
Communicate application progress to internal stakeholders
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
Ensure compliance with product post-marketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Technical File Creation and Maintenance (full life cycle)
Labeling content creation and review
Global Submission Preparation and Review, including country specific support
Compendial / standard compliance
Compile and submit 510(k)'s and deficiency responses
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology); math, engineering, or medical fields is preferred.
M.S. in a technical area or M.B.A. is beneficial.
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus
5 -8 years of experience in a regulated industry (e.g., medical devices, combination products) Note: Higher education may compensate for years of experience
Must have knowledge of ethical guideline