Director, Regulatory Affairs, MDD, MDR, FDA, Global Regulations in Baltimore, MD at Apex Life Sciences

Date Posted: 5/28/2018

Job Snapshot

Job Description


Director, Regulatory Affairs (IVD, MDD, MDR, FDA, CFDA, PMDA, RAC, Global International Regulations) 

Summary

Director of Regulatory Affairs will support the regulatory submission teams to enable global access to our In Vitro Diagnostic (IVD) products. Qualified candidates will have extensive knowledge of domestic and international regulatory requirements; as well as CE Marking Technical File or Design Dossier steps intended to demonstrate compliance of Medical Devices with International requirements.

Key Responsibilities Include: 

  • Lead the submission of documents to FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
  • Direct the submission of documents to CFDA, PMDA, and other Asian markets.
  • Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets.
  • Develop and approve appropriate technical documents for regulatory planning in support of project development
  • Compiling technical file or design dossier. Oversee CE Marking Technical File or Design Dossier (Class III) steps
  • Develop and maintain Technical Files for CE marking.
  • Assess regulatory impact of post-market changes to labeling, design, materials, or manufacturing process.
  • Represent regulatory affairs on product development teams.
  • Identify and implement process improvements for regulatory affairs
  • Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements.

Qualifications & Desired Skill Set:

  • Requires 6-8 +years in Regulatory Affairs in the Medical Device industry
  • IVD experience highly preferred. In Vitro Diagnostic (IVD)
  • Experience in ex-US regulatory submissions required.
  • Experience with CE Marking process. Technical File or Design Dossier and medical device compliance with European requirements.
  • Minimum Bachelor’s (BS) degree in a technical discipline required; Master’s (MS) Degree 
  • Regulatory Affairs Certification (RAC) preferred.
  • Must be able to work independently and efficiently to complete multiple projects within deadline.

FOR IMMEDIATE CONSIDERATION please e-mail your resume to mmoncrieffe@apexlifesciences.com and add #835137 - Director, Regulatory Affairs to the subject of your e-mail.

KEYWORDS: Director, Regulatory Affairs, Compliance, Regulations, International, Global, medical Device, IVD, MDD, MDR, FDA, CFDA, PMDA, RAC, Global, International, CE Marking, Technical File, Design Dossier, Class III, CE Marking, Medical Devices Directive 93/42/EEC, MDD, Medical Devices Directive 98/79/EC, Active Implantable Medical Devices Directive 90/385/EEC, Europe's new Medical Devices Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), Medical Devices, IVDs, MDR/IVDR transition.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.