28 Apr
Regulatory Affairs Manager
Indiana, Batesville 00000 Batesville USA

Vacancy expired!

DescriptionThe 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

#INDHRQualificationsQualifications:

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

Job: QualityPrimary Location: United States-Indiana-BatesvilleSchedule Full-timeTravel Yes, 10 % of the TimePosting Entity HillromReq ID: 20122968

Vacancy expired!


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