Senior Regulatory Affairs Specialist – East Coast Preferred

This is a fully remote position, open to applicants in California.

📋 Description

• Assist in the creation, leadership, and authorship of documentation that supports high-quality regulatory submissions.

• Collaborate with engineers, quality assurance, clinical, and other technical specialists to formulate compliance strategies.

• Prepare and oversee global regulatory submissions for EU MDR, FDA IDE/PMA, LATAM, and APAC regions.

• Provide guidance on regulatory strategies for both developing and marketed products.

• Lead initiatives aimed at improving processes to enhance regulatory efficiency.

• Ensure continuous compliance with QSR, ISO, and MDSAP standards.

• Act as the regulatory representative for significant projects and programs.

• Convey regulatory requirements and their implications to project teams.

• Support global regulatory strategies for new and evolving products.

• Interact directly with regulatory agencies.

• Prepare and submit PMAs, PMA-A/Ss, IDEs, Technical Files, and Change Notifications.

• Identify and develop best practices within the Regulatory Affairs domain.

• Assist in internal and external audits.

• Offer guidance to fellow regulatory team members.

• Support regulatory compliance activities throughout the organization.

• Monitor emerging and evolving regulatory and quality system requirements.

⛳️ Requirements

• Extensive experience with PMA authorship and submissions.

• Bachelor's degree in Science, Pharmacology, or a related discipline.

• Over 5 years of regulatory experience in the medical device or pharmaceutical sectors.

• Demonstrated success with Class III device submissions and CE Marking.

• Experience with Class III Medical Devices.

• Familiarity with IDE, PMA, Design Dossier/Change Notifications, and Shonin Applications.

• Proficient in English.

• Required US work authorization.

• Must not need sponsorship for a work-authorized visa.

• Excellent written, organizational, verbal, and project management capabilities.

• Ability to work efficiently in cross-functional teams.

• Capacity to manage multiple competing priorities and programs with minimal supervision.

• Strong technical skills, critical thinking, and sound decision-making abilities.

• Leadership or mentorship experience in regulatory affairs is preferred.

• Preferred global regulatory knowledge across multiple regions.

• Experience with coronary/peripheral products is a plus.

• Experience with combination products is also preferred.

🏝️ Benefits

• Equal opportunity employment.

• Inclusive, equitable, and welcoming working and learning environments.

• Talent Community access to company news, career opportunities, and events.