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.
The Role: You will be responsible for : Working closely with Team Executives as well as other support functions to provide proactive and effective general administrative assistance across a diverse range of tasks. Scheduling and coordinating meetings. Making...
...Paid Training & Certification: CNA course provided at no cost (training fees covered, but training is unpaid) Cares Dementia Certification paid training provided Community-Based Residential Facility (CBRF) Certification paid training provided...
...the country and get paid your way. Work for yourself - be your own boss. Work whenever and wherever you want, as much or as little as... ...Any car, scooter, or bicycle (in select cities) Valid driver's license & insurance (for car or scooter) Smartphone (iPhone...
...0 sign on bonus, after 60 days of employment full time ******$500 sign on bonus, after 60 days of employment part time *** The Massage Studio is currently seeking LMT's to join our growing team! We are looking for our therapists to deliver our Signature Massage to our...
...About the job Work from Home Booking Agent We are looking for candidates who have strong interpersonal and communication skills... .... Have a laptop or desktop computer. This is an entry level position for those looking to enter the field of Travel Advisory...