Senior Program Lead, Regulatory Affairs

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Job description

Senior Program Lead, Regulatory Affairs

Kelly Services is currently seeking a Sr Program Regulatory Affairs Lead for a long-term engagement with one of our Global Pharmaceutical clients in Irvine CA. This opportunity would be open to remote based employees but prefer the ability to come into the office when needed.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time

Job Description

• Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
• Instill and drive a regulatory culture.
• Develop Technical Documentation for class II and III medical devices to support CE Mark approval.
• Conduct submission negotiations with the European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
• Maintain proficiency on regulatory requirements and develop and maintain rapport with Notified Body reviewers, project team members.
• Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
• Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.
• Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications

• A minimum of Bachelor's Degree in Engineering, Physical or Biological science or related field is required.
• A minimum of 6 years experience in the medical device industry with at least 5 years in Regulatory Affairs of Medical Devices is required.
• Regulatory experience with devices containing software preferred.
• Regulatory submission experience for EU MDR is required.
• Working knowledge of the Medical Device Regulation (EU) 2017/745 (MDR) is required.
• Knowledge of other international medical device requirements (e.g. China, Japan, Australia, Brazil, Russia) is preferred.
• International clinical and regulatory experience is desired.
• Experience in the cardiovascular/cardiology field is preferred.
• RA lead on cross-functional teams (negotiation, leading RA strategy globally) is required.
• Strong interpersonal, organizational, and problem-solving skills are required.
• Strong negotiation/communication skill with Notified Body is required.
• This position will be located in Irvine, CA or remote for the right candidate. Domestic and international travel up to 10% may be required.

#ACRP

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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