What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Kelly Science, Engineering, Technology & Telecom?
Join Kelly FSP as a Sr. Regulatory Affairs Specialist with our Medical Device client in Irvine, California!
This is a hybrid position Monday/Wednesday and every other Friday on site
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 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
