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.

 Location:  Minneapolis - St. Paul Metro area or Skaneateles Falls, New York 

Responsibilities:  

• 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, pre-clinical 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 pre-clinical, 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