Regulatory Affairs Associate Job in Lake Forest, Illinois US
Regulatory Affairs Associate
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a contract opportunity for a Regulatory Affairs Associate for our client in North Chicago, IL. As a Regulatory Affairs Associate, you will be responsible for product registrations and submissions, which includes: · Filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. · Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). · Review/approval of engineering study protocols/reports and validation study protocols/reports. · Review and approval of manufacturing changes for Class III implantable medical devices. · Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; · Requires managing a large amount of data. · Strong office skills are a must. EDUCATION/EXPERIENCE Qualified candidates should have a Bachelor?s degree in a Science related field. A Master?s degree is preferred. In addition, candidates should have experience in Regulatory Affairs. Candidates with previous CMC experience will be given preference. International regulatory experience is a plus. If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted. Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.