Sano Bioscience Int'l  
 
 

Manager to Director Regulatory

Key Job Responsibilities :

Our Client is partnering with a large corporation and taking a lead on the submission of devices to the FDA. They are looking for a Regulatory Director who is well versed with the FDA regulatory process and can lead a new business unit in the regulatory area. This person will develop and implement strategies that to ensure the timely introduction of medical devices into the domestic and international markets. Candidate will oversee preparation of well-organized, complete and scientifically sound 510(k) and PMA regulatory submissions. Lead interactions and discussions with Regulatory Agencies to resolve issues arising during the regulatory submission review process to ensure a timely approval process

Required :

Thorough knowledge of FDA regulations, guidance and policy regarding medical devices and IVD devices. Proven problem solver. Excellent leadership and teamwork skills. Excellent written and verbal communication skills and negotiation skills. General knowledge of statistics. Computer proficiency, including Windows XP based software.

Bachelors degree; Regulatory Affairs Certified (RAC) a plus. 5-8 years regulatory professional experience in the medical device industry. General knowledge of in vitro diagnostic human health care products.

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Director, Quality, Clinical and Regulatory Affairs

Responsibilities:

Manage the regulatory compliance function to ensure compliance with requirements of relevant regulatory bodies, such as FDA (CDRH), California State and local regulations (OSHA and EPA).
Develop regulatory options for commercial applications of in vitro diagnostic products.
Manage compliance with relevant regulatory bodies, and published/practiced regulations and guidelines: CFR, GLP's, and GCP's; GMPs and QSR; ISO 9000, state and local agencies.
Prepare regulatory submissions for US registration, including 510(k)'s and PMA's.
Review labeling, manufacturing, clinical documents and clinical sites for regulatory compliance.
Establish relationship with the FDA as liaison CDRH on all submissions, filings, and communications related to the development of assigned products.
Assist with developing clinical study designs, clinical protocols and submissions associated with clinical studies.
Establish and track department budget.

Qualifications:

Degree in Life Sciences, Engineering or other relevant science preferred.
Expert knowledge of GMP's, CFR, and Quality System Regulation (QSR).
RA and GMP/QA combined experience preferred
Familiarity with global regulations for diagnostic products.
Seven to ten years medical industry experience including direct experience with in vitro diagnostic products.
Hands-on experience with the IDE/PMA and 510K regulatory processes, including FDA or global regulatory agency contact, along with demonstrated work experience in FDA clearance and/or approval.

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Director, Regulatory Affairs

* Reports to the VP Drug Development
* Supervise one direct report, will need to hire 1-2 additional staff
* Candidate with 8-10 years submission experience in small molecule drugs, (some biologic experience OK)
* Strong IND due to the early stage clinical pipeline compounds
* 3-5 years management experience
ADDED PLUS
* Experience with NDA through approval
* Experience reviewing advertising and promotional material
* International experience

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Director/Manager Regulatory Affairs

Responsible for developing and implementing regulatory approval strategies, milestones, and procedures. Develops and implements policies and procedures to ensure compliance with FDA requirements. This individual will be the company's liaison with FDA.

This position requires an experienced professional with FDA regulatory experience to meet clinical regulatory challenges. Successful candidate will have a minimum of a BS + 10 yrs exp or an MS degree and 7+ yrs exp in regulatory affairs. Infectious disease experience preferred. The candidate will be fully involved and provide leadership in the following activities:

  • Regulatory responsibility
    o FDA liaison
    o Preparation of FDA submissions including DMF, IND, NDA and related supplements
    o Report writing and editing
    o Orphan drug applications
    o Fast-track application
    o Labeling/package insert preparation
  • Administration
    o Budget planning
    o Project timeline planning
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