Regulatory Affairs Specialist

1 week ago

Derwood, Maryland, United States AgNovos Healthcare Full time
Job Title: Regulatory Affairs Specialist

AgNovos Healthcare is seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements in the EU, US FDA, and other countries.



Key Responsibilities:


  • Coordinate and provide regulatory support for international regulatory submissions and FDA submissions (e.g., IDE and PMA)
  • Maintain and update Technical Files and Design Dossiers upon request to ensure compliance with current regulatory and company standards
  • Coordinate and prepare materials and presentations for internal meetings and FDA meetings, utilizing Microsoft Office Suite tools
  • Maintain tracking tools for all regulatory submissions, communications, and documentation
  • Provide support to the Quality Assurance department for document control, audits, complaint handling, and CAPAs
  • Track reporting requirements and filing deadlines and keep the team informed
  • Coordinate with Manufacturing/Operations and complete regulatory requirements for Import/Export/Customs
  • Review regulations and guidance to keep apprised of regulatory changes and new regulatory developments


Requirements:


  • BS/BA degree required in science/health-related field
  • Six years hands-on experience performing Regulatory Affairs support activities
  • Skilled at managing cross-functional regulatory projects
  • Ability to read, analyze, and interpret professional journals, technical procedures, SOPs, guidance, standards, and regulations
  • Ability to learn and understand scientific and technical aspects of Class II and III medical devices
  • Experience with regulatory submissions in the US and EU: 510(K), PMA, and CE Technical Files/Design Dossier preferred
  • Reliable and excellent attention to detail
  • Excellent oral and written communication skills
  • Highly collaborative and works effectively in teams
  • Highly organized with the ability to meet deadlines, and be flexible to changing priorities
  • Demonstrates good documentation practice including but not limited to - proof reading, formatting, indexing, record keeping, etc.
  • Excellent computer skills, with a focused proficiency in MS Office and Adobe Acrobat
  • Ability to work with minimum supervision and thrive under pressure
  • Demonstrates analytical and problem-solving skills


AgNovos Healthcare offers a comprehensive suite of benefits including medical, dental, and vision coverage to a 401(k) plan with company match. This position is on a hybrid schedule, with the candidate expected to work in the Rockville office 3 days per week.



Why Join Us:

At AgNovos Healthcare, we are committed to transforming the landscape of bone health. Our team is passionate about developing new treatments leveraging regenerative medicine to address persistent unmet medical needs related to bone disease. We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team and contribute to our mission.



How to Apply:

Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you

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