Regulatory Affairs Manager, Palm Harbor, FL - Palm Harbor, Florida United States - 23153

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JOB DESCRIPTION

Job #: 23153
Title: Regulatory Affairs Manager, Palm Harbor, FL
Job Location: Palm Harbor, Florida - United States
Employment Type:
Salary: $105,000.00 - $110,000.00 - US Dollars - Yearly
Other Compensation: plus bonus
Employer Will Recruit From: Regional
Relocation package is a lump sum up to $7500
Relocation Paid?: Yes

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.  . 

 

JOB DESCRIPTION

  • 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

QUALIFICATIONS

  • 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

Education:
University - Bachelor's Degree/3-4 Year Degree