Purpose
We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team in Miami. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution.
Responsibilities
· Lead regulatory strategy and submissions for Class II and III medical devices in the U.S.
· Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports
· Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions.
· Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials.
· Monitor changes in regulatory requirements and communicate impact to internal stakeholders.
· Support audits and inspections by regulatory authorities.
· Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals.
· Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards.
Qualifications
· Bachelor’s degree in engineering, life sciences, pharmacy, or related field. Advanced degree preferred.
· Minimum 10 years of experience in regulatory affairs within the medical device industry.
· Proven track record of successful submissions to FDA
· In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards.
· Strong communication, leadership, and project management skills.
· Experience with eQMS systems and electronic document control preferred.
...Design and implement digital hardware architectures for high-bandwidth interconnects and memory controllers. In this role, you will develop digital hardware for next-generation interconnects and memory sub-systems. lead digital RTL design, verification, and bring...
...At Five Below our growth is a result of the people who embrace our purpose: We know life is way better when you are free to Let Go & Have Fun in an amazing experience, filled with unlimited possibilities, priced so low, you can always say yes to the newest, coolest stuff...
...Job Description We are seeking a dedicated Physician to join our diverse team in Springfield, MO, at a modern urgent care center... ...include board certification or eligibility in Family Medicine, Emergency Medicine, or Med/Peds, with experience treating all ages and...
At Phyt Rehab, we bring quality rehab services directly to our patients doors! From Physical and Occupational Therapy to Speech Therapy, our goal is to help our patient regain strength, confidence, and independence all from the comfort of home. Were proud to be a...
...nine diverse industry sectors. With offices in San Francisco, Portland, and Seattle, we operate along the entire West Coast. Our architects and designers are dedicated to helping communities flourish every day. Why join us? 100% paid benefits - medical, dental &...