Regulatory Affairs Specialist II

Kelly Science, Engineering, Technology & Telecom; Irvine (CA); In loco; USD 140.000 - 180.000; Tempo pieno

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom in Irvine, CA seeks an experienced Regulatory Affairs professional to lead global regulatory strategy for medical devices. The role requires crafting regulatory pathways, coordinating 510(k)/PMA submissions in the US and EU assessments, and negotiating with FDA and Notified Bodies.

You will drive lifecycle regulatory activities, maintain agency relationships, and mentor cross-functional teams.

Competenze

• Bachelor’s degree in engineering, physical or biological sciences or related field.
• Minimum 4 years in Regulatory Affairs within the medical device industry.
• US and/or EU submissions experience preferred.
• Experience in cardiovascular/cardiology field preferred.
• RA lead on cross-functional teams with global strategy preferred.
• Strong negotiation, communication, and project management skills required.
• Ability to travel up to 10% (domestic/international).

Mansioni

• Ensure compliance with global regulations and agencies.
• Develop and implement regulatory strategies for timely global commercialization.
• Develop 510k/PMA submissions and US assessments for class II and III medical devices.
• Prepare Technical Documentation and EU assessments.
• Conduct FDA/Notified Body submission negotiations and strategy.
• Maintain proficiency on regulatory requirements and liaise with FDA/Notified Body reviewers.
• Represent RA in lifecycle management project teams.
• Provide regulatory education and disseminate information to product development, marketing, and clinical groups.
• Generate documentation for worldwide regulatory approvals to market products.
• Collaborate with teams to achieve strategy and communicate issues to management.
• Adhere to Health, Safety, and Environmental guidelines.

Conoscenze

Negotiation

Communication

Project management

Interpersonal skills

Organizational skills

Problem solving

Presentation skills

Formazione

Bachelor’s degree in Engineering or Physical/Biological sciences

Descrizione del lavoro

• 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.