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Director, Regulatory & Quality (m/f) for Medical Devices - United States  

Company managed [?] Still accepting applications
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Posted on : 24 May 2017

Project Description

Be a part of our growing company!
  • Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? 
  • Our company  is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting.
  •  We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities.
  • The success of our company resides in the expert knowledge and high motivation of our employees.
  • We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. 
  • So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. 



Director, Regulatory & Quality (m/f) for Medical Devices
  • The Director, Regulatory & Quality (Dir, RA/QA) leads the overall global strategy for regulatory affairs and quality systems by partnering with functional groups to establish product regulatory and quality strategies as well as support the clinical affairs team. 
  • The Dir, RA/QA oversees and manages the RA/QA organization, assuring policies and procedures comply with all applicable requirements from regulatory or certifying organizations in all countries or regions where the company markets products, including, but not limited to FDA, Notified Bodies, EU Competent Authorities, Health Canada, CFDA, PMDA, and TGA. Works cross-functionally to ensure compliance with policies and procedures. 
  • The Dir serves as a liaison between the company and various governmental agencies and regulatory bodies, including the FDA, on all relevant issues. 
  • Encourages and strongly supports continuous quality improvement in all functional areas and focuses on internal and external customer satisfaction.
  • For operational issues, the Dir reports to our client´s General Counsel & Secretary, with a dotted line reporting relationship to their CEO. For internal issues, the Dir reports to the COO.



Your responsibilities 
  • Responsible for ongoing development and maintenance of the Quality Management System.
  • Responsible for worldwide regulatory filings and other related regulatory filings.
  • Develop, document, and implement regulatory strategy for new technologies and product modifications.
  • Interface with FDA and other regulatory agencies regarding regulatory submission strategy and approval reviews.
  • Review labeling and marketing/promotional materials for claims/compliance to regulatory approvals and global regulatory requirements.
  • Collaborate with Clinical Affairs to develop clinical trial plans and reports.
  • Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
  • Establish and maintain a professional and credible image with FDA, and other regulatory agencies.
  • Provide regulatory affairs support to the document control/change request system.
  • Provide direction and guidance for FDA Medical Device Reporting and EU Medical Device Vigilance Reporting related to product complaints and adverse events
  • Foster a quality-focused, cost conscious, continuous improvement culture within the company by advancing quality assurance methodologies with an eye toward simplifying processes.




Your profile
  • Bachelors Degree in Life Sciences, Engineering, or Similar. Advanced degree preferred.
  • Minimum 5-10 years experience in the medical device Regulatory/Quality profession; interventional cardiology experience is a plus.
  • Management of budgets and staff.
  • Regulatory Affairs Certification (RAC) is preferred
  • Experience with regulatory submission processes in the US, EU, Canada, and other international markets highly preferred
  • Successful track record in gaining global regulatory clearances
  • Excellent communication, organization, and project management skills



Working Conditions
Physical requirements associated with a typical office working environment




We offer you
  • Exciting and varied challenges in a friendly, team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training.
  • If you are interested to take up the challenge at our future-oriented company, and would like to grow together with our company, please send us your detailed application including desired salary and earliest starting date via e-mail.