Tuesday, June 12, 2012

[itroundtable] LEAD: Position for Regulatory Affairs Manager - Bridgewater, NJ

Please contact Keyur directly [ Keyur.Patel@cyberThink.com] and let him know that I sent you.

Ann Bergquist

http://www.linkedin.com/in/annbergquist

Our client is looking for Regulatory Affairs Manager  to join their Bridgewater NJ office.

 

If you are not looking then pls. forward it to your network who is looking for new opportunity.

 

No. of positions – 2

Location – Bridgewater, NJ

Duration – Fulltime / Permanent

Job Description :

 The Regulatory Affairs Manager is responsible for:

         Ensuring that new LifeCell products and changes to existing LifeCell products are prepared and submitted in a timeline manner to Regulatory Agencies in all targeted markets

         Interfacing with cross-functional development teams, Regulatory Agencies and distribution partners

         Overseeing the work of entry level regulatory affairs personnel including training, mentoring and ensuring professional development

 

Primary Duties/Responsibilities:

          Manages and develops regulatory staff

         Responsible for oversight and prioritization of personnel tasks and projects

         Prepares and supports regulatory submissions (510(k)s ,Dossiers, etc) in a timely manner meeting current regulations and guidance document requirements

         Tracks and incorporates American Association of Tissue Bank Guidelines into filings

         Ensures filings avoid conflicts between AATB and 21 CFR 1271 and appropriate international regulations

         Primary contact and representative for all interactions with Regulatory Agencies for assigned projects

         Participates on project teams representing Regulatory Affairs to provide inputs and answer questions related to regulatory requirements

         Ensures regulatory milestones for assigned projects are met

         Prepares regulatory strategies for medical devices and human tissue products to determine regulatory pathways to market including FDA "Letter to File" rationales for devices. Communicates regulatory strategy and updates, as necessary, depending upon new information generated during development

         Reviews product labeling to assure compliance with regulatory requirements for medical devices and human tissue products

         Review promotional material for human tissue products and medical devices to assure claims and indications are consistent with approved language/current product classifications

         Ensures working knowledge of assigned products, including claims and associated requirements, in order to perform adequate reviews and compliance with standard operating procedures

         Interprets and applies FDA and International regulations to business practices and provides regulatory input, advice and guidance to the organization

         Monitors, tracks and actively assesses evolving FDA regulations, guidances, points-to-consider, warning letters and policies

         Monitors current developments and potential changes and opportunities in the US and other regulatory jurisdictions

 

Qualifications:

Position Qualification Requirements:

Basic Qualifications:

         Bachelor's Degree in Biological Science or related field

         At least 5 years' experience in managing Regulatory Affairs in a healthcare environment

         Experience with Microsoft Office applications including:  Word, Excel, & Outlook

 

Other Position Qualifications:

In addition to the basic qualifications listed above, the following other position qualifications are required:

         Experience working with FDA and International regulations, including but not limited to: 21 CFR 807, 21 CFR 820, ISO 13485, MDD 93/42/EEC, TGA Medical Device Regulations and SOR/98-282.

         Experience filing submissions in the US and International markets, particularly medical devices.

         Experience with regulatory Global devices

         Experience managing functional groups in the development of relevant data to complete a regulatory submission

         Demonstrated communication and presentation skills

         Demonstrated attention to detail and organizational skills

         Ability to lead a team, influence other and handle increasing levels of responsibilities

         Ability to build relationships between Regulatory Affairs and other areas of the organization

         Ability to oversee day-to-day performance of employees, organize a group and provide leadership

         Ability to manage/supervise employees with ability to accomplish objectives

         Knowledge of Human Cellular and Tissue Product regulations (21 CFR 1270/1271)

 

 Preferred Qualifications:

In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:

         Certifications such as ASQ and Six Sigma

         RAC (US) certification

         Member of RAPS (Regulatory Affairs Professional Society)

 

Please provide the following details along with your updated resume in word format….

Availability for an interview:
Availability for start:
Contact number:
Best time to call you:
Current location:
Currently on project:
If NO, then when was your last assignment ended:
Reason for ending last assignment / Reason for searching a new job:
Expected hourly rate on W2 no benefits basis::

Work authorization status in USA:
Is commute feasible for you on daily basis?      

 

Keyur Patel
cyberThink, Inc

1125 US Hwy 22, Suite 1
Bridgewater, NJ 08807
Phone: (908) 429-8008 ext. 354

Cell: 908-875-3692

Fax: (908) 429-8004
Email:
keyur.patel@cyberthink.com
Website: www.cyberThink.com

 

Gmail: keyur.p.patel@gmail.com

Connect to me:  

Click here to view current job openings.

 

 ___________________________________________________________________________________________________________________________________________
cyberThink, Inc. is a Certified Minority-Owned Business (MBE) and has been recognized as one of the fastest growing IT Services and Staffing companies in the U.S. by INC. magazine, Deloitte & Touche and Purple Squirrel.
cyberThink, Inc. is an Equal Opportunity Employer (EEO).
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