Senior Regulatory Affairs Specialist

Cordis • Irvine, CA

5d

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Requirements

• Bachelor’s degree in Science, Pharmacology, or related field.
• 5 + years of regulatory experience in medical device or pharma.
• Proven success with Class III device submissions and CE Marking.
• Experience with Class III Medical Devices.
• Experience with a variety of submission types including: IDE, PMA, Design Dossier/Change Notifications, Shonin Applications.
• Fluent in English.
• Strong written, organizational, verbal and project management skills.
• Ability to work effectively in cross functional teams.
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
• Enjoy collaborating with others and creating alignment with team members.
• Strong technical skills, critical thinking, and sound decision making.
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Nice To Haves

• Leadership or mentorship experience in regulatory affairs.
• Global regulatory knowledge across multiple regions.
• Experience with coronary/peripheral products
• Experience with combination products

Responsibilities

• Assist, lead and author documentation to support high-quality regulatory submissions.
• Work closely with engineers, quality assurance, clinical and other technical experts to develop strategies to ensure compliance to regulations and to assist in responding to questions from regulatory authorities.
• Prepare and manage global regulatory submissions (EU MDR, FDA IDE/PMA, LATAM, APAC).
• Advise on regulatory strategies for development and marketed products.
• Lead process improvement initiatives to increase regulatory efficiency.
• Ensure ongoing compliance with QSR, ISO, and MDSAP requirements.
• Act as a regulatory representative on large projects/programs to provide regulatory strategy and planning in line with Product Development Procedure and Quality System requirements.
• Communicate regulatory requirements and impact of regulations to project teams.
• Assist with development of global regulatory strategies for new and changing products.
• Direct interaction with regulatory agencies.
• Prepare and submit PMA’s, PMA-A/S’s, IDE’s, Technical Files, Change Notifications.
• Identify and develop best practices within the Regulatory Affairs Department.
• Support internal and external audits.
• Provide guidance and advice to other regulatory team members.
• Support regulatory compliance activities within business and corporation.
• Keep abreast of new and changing regulatory and quality system requirements.

Benefits

• The expected pre-tax pay rate for this position is $89,000 – $119,000 annually. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior