Consultant, Medical Devices, Regulatory Affairs Specialist - IVD
GForce Life Sciences
February 15, 2018
Franklin Lakes, New Jersey
Contract - Experienced
European Union Regulatory Affairs, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Our client, a global medical device manufacturer, has engaged GForce Life Sciences to identify a Regulatory Affairs Specialist who will be responsible for coordinating, preparing, and maintaining regulatory submissions and related documents for Class II devices in the U.S. and Europe (in addition to support the daily departmental workload).
Duties / Expectations of Role
Provide guidance on regulatory submission strategy based on a strong demonstrated understanding of current guidelines outlined by regulatory authorities in the United States and Europe
Determine appropriate regulatory pathways for assigned Class II devices based on product classification and type of submission/rationale required
Prepare, maintain, and review regulatory documents for new and modified in vitro diagnostic devices (IVDs) including, but not limited to, Technical Files, Clinical Evaluation Reports (CERs), 510(k)s, Product Development Protocols (PDP), Pre-Market Approval Applications (PMA), and Investigational Device Exemptions (IDE)
Interact with regulatory agencies and provide necessary data/support as needed
Collaborate closely with cross-functional team, including product development/R&D teams to determine appropriate regulatory strategies
Maintain current knowledge of existing and emerging regulatory guidelines (U.S. and Europe) such as EU IVDR
Review change control documents and ascertain regulatory impact for internal and external documents
Compile and maintain regulatory documentation databases or systems
Author and/or review regulatory procedures and update as necessary
Bachelor’s Degree in Biology, Chemistry, or related field
4+ years of related medical device industry experience (in Regulatory Affairs), preferably working with IVDs
Must have experience successfully preparing and submitting 510(k) and/or PMA submissions for Class II devices
Proficient knowledge of Class II medical device (IVD) regulations in the United States and Europe
Nice to Have Requirements
Advanced degree in Biology, Chemistry, or related field
Regulatory Affairs Certification (RAC)
Knowledge of medical device and vigilance reporting requirements in the U.S. and Europe
This position will be based in Northeastern New Jersey
Term & Start
Internal Number: 572
About GForce Life Sciences
GForce Life Sciences connects highly coveted consultants to the needs of life sciences leaders.
Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency.
With a 98% success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants to assist our clients in delivering on the promises they have made to their clients (internal and external).
GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant or team that is the best fit.
Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best consultants for your company and projects.
Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.