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Director, Regulatory Affairs
Hiring Company Industry:
Legal Services
Number of Employees:
1,000 - 10,000
Employees
Total Compensation: $100K+
Location: New York, NY
JOB DESCRIPTION
About the company :
Our client is a well-known manufacturer of Medical Devices located in the New York City Metro area. We are assisting this client with their search for a Director, Regulatory Affairs, to support a specific product line within the organization. Job description :
In this role as Director, Regulatory Affairs, you will be responsible for supporting all Regulatory Affairs as they relate to a specific product offering in our clients line. You will act as a business partner, supporting the development, sales and marketing teams to assess and plan for ever-changing governmental regulations on a global scale.Specifically, we are looking for an individual who has CURRENT experience with the following: In-depth understanding of ALL FDA and international regulatory requirements Hands-on, primary experience with the following documents: New Drug Applications, Investigational New Drug, Investigational Device Exemptions, Premarket Approval Applications, 510(k), (PMA, IND, IDE, NDA, etc.) Coordinate due-diligence activities with multiple internal teams Who we are looking for :
The proper candidate will have: AT LEAST ten years experience in FDA Regulatory Affairs Advanced degrees are HIGHLY PREFERRED - PhD or MS in Chemistry, Biology, Life Sciences, etc. JD is a plus Prior experience can be in device or drug products Whats on offer :
On offer is an extremely competitive base salary and significant opportunity for growth within an expanding organization. Full benefits and vacation package plus bonus potential apply as well.To apply directly for this position please forward a detailed resume along with current salary, in strict confidence by applying on the Michael Page website : http://www.michaelpage.com/job-advert/1195500-director-regulatory-affairs.htmlsrc=LD
Our client is a well-known manufacturer of Medical Devices located in the New York City Metro area. We are assisting this client with their search for a Director, Regulatory Affairs, to support a specific product line within the organization. Job description :
In this role as Director, Regulatory Affairs, you will be responsible for supporting all Regulatory Affairs as they relate to a specific product offering in our clients line. You will act as a business partner, supporting the development, sales and marketing teams to assess and plan for ever-changing governmental regulations on a global scale.Specifically, we are looking for an individual who has CURRENT experience with the following: In-depth understanding of ALL FDA and international regulatory requirements Hands-on, primary experience with the following documents: New Drug Applications, Investigational New Drug, Investigational Device Exemptions, Premarket Approval Applications, 510(k), (PMA, IND, IDE, NDA, etc.) Coordinate due-diligence activities with multiple internal teams Who we are looking for :
The proper candidate will have: AT LEAST ten years experience in FDA Regulatory Affairs Advanced degrees are HIGHLY PREFERRED - PhD or MS in Chemistry, Biology, Life Sciences, etc. JD is a plus Prior experience can be in device or drug products Whats on offer :
On offer is an extremely competitive base salary and significant opportunity for growth within an expanding organization. Full benefits and vacation package plus bonus potential apply as well.To apply directly for this position please forward a detailed resume along with current salary, in strict confidence by applying on the Michael Page website : http://www.michaelpage.com/job-advert/1195500-director-regulatory-affairs.htmlsrc=LD
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