Senior Regulatory Affairs Specialist

Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist II for a long term engagement in Irvine, CA with one of our Global clients. 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.
Regulatory Affairs Specialist II
Job Description
Anticipated Start - January 4th
In this role, you will:

• Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
• Develop and implement regulatory strategies and processes to ensure timely global commercialization of products/changes in compliance with applicable regulations and standards.
• Develop 510k/PMA submissions and US assessments for class II and III medical devices.
• Develop Technical Documentations and EU assessments.
• Conduct submission negotiations with the FDA/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 FDA/ Notified Body reviewers, project team members.
• Represent RA in life cycle management project team.
• 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 client 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 following 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 4 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required. (Or Advanced degree with 2 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required)
• Experience of US and/or EU submission is preferred.
• Experience in the cardiovascular/cardiology field is preferred.
• International clinical and regulatory experience desired.
• RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is preferred.
• Strong negotiation/communication skill is required.
• Strong project management skill is required.
• Strong interpersonal, organizational, and problem-solving skills are required.
• Strong presentation skill is required.
• This position will be located in Irvine, CA.. Domestic and international travel up to 10% may be required.