Can you recommend someone for this job: Quality Regulatory Director at NewTown Solutions
From:Christine Smith
Date:June 3, 2008
To:John Reinke
Hope you are having a great day. If you have a moment, I’d appreciate your help. Please take a look and forward this job on to anyone you think would be interested in the position, or anyone else who could help me find a great candidate. We offer a $1,000 referral bonus for anyone who is hired.
Thanks for your help!
-Christine
Company: NewTown Solutions
Job Title: Quality Regulatory Director
Description: The position will be working in the product business unit and report to the VP, Quality & Regulatory. Provides oversight and management responsibility for the functional areas of the Quality and Regulatory organization. Serves as the management representative for the assigned site. Assures that quality of products and services meets internal and external customer requirements.
1. Provide direction and leadership for Quality and Regulatory departments. (30%)
2. Ensure quality system compliance to US and international regulations including EN ISO 13485 and 21CFR 820 Quality System Regulation. Has ownership for regulatory submissions (510K, PMA). Develop, direct and coordinate the execution of regulatory strategies for EnSite business unit. (30%)
3. Develop, implement and improve quality processes and procedures, automated systems and reporting systems. (15%)
4. Ensure product acceptance activities are handled in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the Quality System. (15%)
5. Serves as the primary contact for external regulatory inspections and audits. (10%)
Qualifications
A Bachelor’s degree in Engineering, Science or related field. Master’s degree preferred. Typically a minimum of 12+ years of progressively more work experience in medical device or high technology product failure analysis and reliability is required. Demonstrated ability to understand and be completely familiar with applicable FDA and TUV regulations and other relevant clinical/regulatory requirements. Must have a successful regulatory track record in the commercialization of innovative, complex medical devices (communications, ID/PMA and Class III and II CE approvals.
Relocation Assistance: Yes
We are definitely looking for PMA experience, leadership experience, and a candidate with a high energy level.
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I have no more information. {Sargent Shultz says “I know nuthin, Nuting, Nothing at all”!} I put it all in the post. Writing me for more info is a waste of your time and mine.
If you’re interested, leave a blog comment with your name and email. I’ll either send you the contact info, or forward your info to them. Depending upon what they prefer. Either way, you’ll get something back from me.
Note: Don’t put your email in the comment itself unless you want spam from a trollbot. The comment form allows you to put your name, email, and website address.
You might want to include a link to a http://www.emurse.com/ resume or such similar site. I recommend making oneself easy to be found.
You might want to take time to write a short cover on it. You never know who reads these things. You might find your own lead from it (i.e., someone, looking to hire an X, finds me saying someone is looking for X, and ‘poaches’ all the people who responded.). YMMV
Good luck and good hunting.
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Reinke Faces Life 