Regulatory Affairs Manager, Palm Harbor, FL - Palm Harbor, Florida United States - 23153
Regulatory Affairs Manager, Palm Harbor, FL
Palm Harbor, Florida - United States
$105,000.00 - $115,000.00 - US Dollars - Yearly
Employer Will Recruit From:
Relocation package is a lump sum up to $7500
WHY IS THIS A GREAT OPPORTUNITY?
As the Regulatory Affairs Manager for a medical device manufacturing company YOU will be leading a team of Regualtory Affairs Specialists executing global regulatory strategies, filing submissions and maintaining compliance with all US and international regulatory guidelines. Supporting a product offering of implantables, venous access systems and diagnostic catheters. .
FDA - Prepare for and file FDA and CE product submissions, update existing product files; maintain establishment and product registrations
Advise on international certifications and approving the filing
Participate in FDA, ISO, customer and supplier audits as needed
Communicate with domestic and international business partners and direct interaction with regulatory agencies on product issues and questions
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Maintain global product regulatory compliance by reviewing design changes, labeling, advertising and promotional materials
Interpret regulatory rules or rule changes and ensure that they are communicated throughout corporate policies and procedures
Provide regulatory guidance to product development and sales teams to ensure successful global product registrations
Bachelor’s Degree or equivalent
5-7 years of progressive experience in both regulatory and quality assurance fields within a FDA and ISO regulated manufacturing environment.
Direct experience with PMAs, 510(k)s, pre-submissions and FDA meetings
Thorough knowledge of global regulatory requirements for medical devices
Direct experience interacting and negotiating with regulatory agencies
University - Bachelor's Degree/3-4 Year Degree