Seeking a Senior Staff Regulatory Affairs Specialist with Regulatory Affairs experience in the device/diagnostic, biologic and/or pharmaceutical industry, working knowledge with medical device and pharmaceutical regulations, product classifications, and applicable device or drug registration requirements AND software, electromechanical and/or digital health medical devices experience for our Franklin Lakes, NJ location.
Summary: In Medical Pharmaceutical Systems-Self Administration Injection Systems, we develop novel and complex drug delivery solutions to allow patients to inject medications themselves. This position, as a Senior Regulatory Subject Matter Expert, will develop and execute regulatory strategies to support stand-alone and combination device constituents in development, prepare compliant master regulatory documents for global compliance, and will lead RA in customer facing for strategic accounts. Join us in our mission to advance the world of health. This group develops drug delivery solutions which will advance smart technology digital health. i.e. this person will work with the apps that send alerts to your smart phone if your blood level drops, etc...
The Senior Staff RA specialist will be working in Medical Pharmaceutical Systems-Self Administration Injection Systems, primarily the Wearable Injection Platform.
Represent regulatory function in complex product development teams and projects by identifying, interpreting relevant regulatory requirements and provide actionable regulatory guidance throughout the product development cycle
Establish and implement regulatory strategies to support cross-functional stand-alone and combination device development for smart devices and digital health solutions for US, EU and other global markets
Establish close partnership with pharmaceutical customers and develop understanding of customer’s regulatory strategies to ensure proper support (throughout drug product approval process) is provided and while protecting interest.
Collect, analyze the registration requirements for similar products, and apply the synthesized regulatory intelligence to assist the business decision making process
Review/approve Drug and Device Master Files (DMF and MAF) for compliance with relevant regulations for submission to US FDA, Health Canada and Australia and coordinate appropriate input/help from various functions (R&D, Quality, Manufacturing, Medical etc.) in a timely manner
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance, as assigned
Reviews clinical, human factor study protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance
Identify ways to improve the efficiency of current work process and execute them.
Keep appraised of the changing regulatory environment and keep the relevant team and supervisors informed about the potential impacts
Support the Pharm Systems US and WW RA team as needed
B.S. degree required with life science or engineering background preferred
Must have experience with software, electromechanical and/or digital health medical devices.
5 + years of Regulatory Affairs experience in the device/diagnostic, biologic and/or pharmaceutical industry
3 years of working knowledge with medical device and pharmaceutical regulations, product classifications, and applicable device or drug registration requirements for US/EU
Current knowledge of U.S. medical device regulatory requirements and Quality System Regulations (QSR) required
Experience working with 510(k), CE Marking, Master Files and eCTD preferred
Experience working with regulators
Customer centric mindset (internal and external)
Ability to network, managing diverse relationships
Ability to effectively cope with change and ambiguity
Regulatory certification (RAC) in medical device and/or drug regulations is a plus
Combination Product regulation understanding is a plus
Fluent in English; French speaking is a plus
U.S. citizen/green card holder required.