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
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
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 guidelines of the regulatory profession, clinical research and regulatory process.
Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents; principles and requirements of applicable product laws
Knowledge of International submission/registration types and requirements; domestic and international guidelines, policies and regulations (GxPs (GCPs, GLPs, GMPs).
Principles and requirements of promotion, advertising, labeling, and EU Medical Device Regulation
Specific medical device experience, particularly with Class I and Class II software and/or hardware developed devices, as well as single use, sterile disposables.
FDA registration and listings
Familiarity with wireless radio approval process
Additional Salary Information: Competitive benefits package available on your first day including medical, dental vision and life insurance; 401k with competitive match, discounted employee stock purchase plan
Internal Number: 19124959
About Hillrom Respiratory Health
In a rapidly changing industry, caregivers remain the constant. Every day they demonstrate their passion for helping people despite unprecedented pressure to increase access and quality of care with the same or fewer resources.
Hillrom is driven by patient-centered care. Everything we do, and all our products and technologies, are designed to enhance outcomes for patients and caregivers.
It starts with cutting through complexity and focusing on the human side of healthcare. By continuously advancing and integrating our solutions, we enable clinicians to be vitally connected to their patients by delivering timely data and actionable insights. That means more accurate diagnoses, earlier intervention and faster recovery times.
Our innovations put more heart in healthcare. Through more intelligent—and more connected—solutions, we help simplify routine workflows and communication, enabling care teams to focus on their passion—helping patients get better sooner. And we continuously raise the bar on quality and safety, building upon our legacy of trust with providers around the world.
As healthcare continues to evolve, we’re here to support the people at the heart of it.
Hillrom. Advancing Connected Care™.