Sr RA Specialist

Kelly Science and Clinical FSP is currently seeking a Senior Regulatory Affairs Specialist for a long-term engagement in the US with one of our Global Medical Device clients in Irvine, California. This position is hybrid, on site Monday and Wednesday. 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, Vision, 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.

Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.

• 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 I, 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
• 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, specifically in class III submission and change management in PLM systems, MDR Technical Documentation, MDR Renewal, and Internal Regulatory Assessments.
• Regulatory experience with devices containing software preferred – Windchill or other PLM system.
• 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.