Karen Young
Email: abou8u@r.postjobfree.com
Address: **** ******* ****
City: New Haven
State: IN
Zip: 46774
Country: USA
Phone: 612-***-****
Skill Level: Experienced
Salary Range: 40
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Karen A. Young
Former Clinical Monitor, Regulatory Affairs, Bone Cement Development Manager, Homemaker.
Self Starting, Detail Oriented, Flexible, Likes People, Committed to Excellence
OBJECTIVE My goal is to secure a full time or part time position where I can make a significant contribution to the success of my employer using my education, experience, and interests in customer service, clinical documentation and regulatory affairs. I am a homemaker transitioning back into the workforce after 17 years and am willing to start over in an entry level position.
SUMMARY DETAIL ORIENTED, demonstrated by track record of successful preparation of FDA Premarket Notifications for clients.
CUSTOMER SERVICE. As a Zimmer Development Manager, received a thank you note form the president of the firm for the exceptional job done in record time to allow Zimmer to market the first low viscosity bone cement in the United States. From a different perspective, I have over 2800 positive feedbacks for sales on eBay, 100% positive within the past 12 months.
FLEXIBLE Able to manage while staying within protocol boundaries to ensure compliance with regulations. I like people and I learned about flexibility as a survival skill while raising 3 teenage sons.
EXPERIENCE Homemaker 1995-2010
Self Employed Consultant in Clinical Monitoring, 510(k) Premarket Notification Preparation-Accomplishments:First Successful 510(k) for carbon tipped cardiac lead, 98% 510(k) Permission to Market Determinations, 10 years experience in managing projects for clients with successful outcomes 1984-1995
Advanced Biosearch Associates 1983, Dublin, CA ACCOMPLISHMENTS: Assisted in IDE Preparations for Bone Growth Stimulator, assisted in IDE/PMA for a new Bone Cement to US Market, Prepared Drafts of 510(k) submissions for client firms
Zimmer 1977-1982 ACCOMPLISHMENTS: As Senior Development Manager, responded to Customer Service Requests for Bone Cement Products, Coordinated with Clinical Research Dept to bring new implantable bone cements to market, Record time to market approval for Low Viscosity Bone Cement.
EDUCATION Purdue University 1973-1977, BS Science, University of St. Francis 1978-1981, MS Business Administration
SKILLS: Attention to detail, Customer service, Technical Writing, Flexibility, Committed to Excellence.
References available upon request.