Regulatory Affairs Manager

Hill-Rom Batesville , IN 47006

Posted 3 weeks ago

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.

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, 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

#INDHR

Qualifications:

  • 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

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Regulatory Affairs Manager

Hill-Rom