Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

About the role

Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.

Responsibilities

• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
• Develops global regulatory strategies for new and modified products.
• Prepares and submits regulatory submissions to health agencies.
• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
• Provides regulatory assessment for manufacturing, design changes and product risk assessment.
• Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
• Plans, schedules, and arranges all activities to support regulatory timelines.
• PARTNERS WITH QUALITY SYSTEM LEADERSHIP TO MAINTAIN REGULATORY AND QUALITY COMPLIANCE REQUIREMENTS, INCLUDING SUPPORT DURING REGULATORY AUDITS.
• Maintains annual licenses, registrations, and listing information.
• AIDES WITH COMPLIANCE TO PRODUCT POST-MARKETING APPROVAL REQUIREMENTS.
• SUPPORTS THE PRODUCT RELEASE PROCESS.
• ACTS AS AN SME FOR INTERNAL AND EXTERNAL AUDITS AND INSPECTIONS BY INTERNAL TEAMS OR EXTERNAL REGULATORY AUTHORITIES.
• COMPLIES WITH US FOOD AND DRUG ADMINISTRATION (FDA) AND INTERNATIONAL REGULATIONS, OTHER REGULATORY REQUIREMENTS, COMPANY POLICIES, AND GOVERNING PROCEDURES AND PROCESSES.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• REVIEWS PROTOCOLS AND REPORTS TO SUPPORT REGULATORY SUBMISSIONS.
• CREATES, REVIEWS AND APPROVES ENGINEERING CHANGE REQUESTS.
• ACTS AS LIASON BETWEEN THE COMPANY AND THE VARIOUS REGULATORY AGENCIES.
• INTERFACES DIRECTLY WITH FDA AND NOTIFIED BODIES.
• PROVIDE INTERPRETATION OF REGULATORY AUTHORITIES’ FEEDBACK, POLICIES AND GUIDELINES.

Qualifications

• 7+ years of working directly with engineering teams experience
• 5+ years of technical product or program management experience
• 5+ years of technical program management working directly with software engineering teams experience
• Experience managing programs across cross functional teams, building processes and coordinating release schedules
• Experience with regulatory filings and reports or equivalent
• Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
• Experience working on multi-team, cross-disciplinary projects
• Experience that includes strong analytical skills, attention to detail, and effective communication abilities
• Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
• Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
• 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
• Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection
• Experience with medical device software requirements