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Regulatory Affairs, Manager

Apply Now Job ID R-345874 Date posted 08/29/2019

Job Description Summary

Job Description

SUMMARY

The Regulatory Affairs Manager is responsible for U.S. and CE marking product activities or International activities related to submissions and registration and working effectively with other country regulatory coordinators to provide submission/registration documentation. In addition, the manager will oversee the activities of the department by managing priorities and providing guidance and development of direct report employees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Plan, coordinate and manage department activities
  • Provide direct supervision to direct report employees as appropriate
  • Assure product compliance with regulatory submission/registration requirements
  • Review regulatory strategy as needed with Bard regulatory personnel for other geographic regions (i.e. Japan, Asia, Canada and Australia/New Zealand) for requested product information and format (i.e. International dossiers and STED) for successful submissions/registrations
  • Develop and facilitate U.S. and CE marking product regulatory submission strategy working with cross functional teams
  • Prepare 510(k), IDE, PMA, Design Dossier and international submissions, as required 
  • Manage Technical Files for CE marking products, as required
  • Participate as a team member in all clinical trial development and activity to ensure compliance with FDA and European regulatory requirements (i.e. IDE) and liaison with the regulatory authorities for reporting requirements  
  • Maintain and manage FDA establishment registrations and device listings
  • Participate in remedial action plan activities and communication with regulatory authorities as required
  • Develop effective working relationships with key personnel/representatives of the FDA Offices of Device Evaluation and Compliance, and notified body
  • Provide regulatory review and guidance for all regulatory post market activities including product labeling and advertising and promotional material review
  • Other duties may be assigned

QUALIFICATIONS:

  • Must have leadership skills that include the ability to prioritize and multi-task for projects within the department
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
  • Must have knowledge of U.S and European product submission and registration requirements for medical devices
  • Must be results orientated along with managing vision and purpose
  • Must have the ability to develop and mentor others within the department promoting open communication and feedback
  • Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

EDUCATION AND/OR EXPERIENCE:

  • BS is a scientific discipline with 5-7 years of employment in the areas of medical device / drug product registration, compliance or quality systems and a minimum of 3 years of personnel experience 
  • Regulatory Affairs Certification (RAC), advanced Degree and Certifications desired

LANGUAGE SKILLS:

  • English communication skills; written and verbal

MATHEMATICAL SKILLS:

  • Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration/submissions

REASONING ABILITY:

  • Must demonstrate the ability to plan and complete regulatory pathway

PHYSICAL DEMANDS:

  • Must be able to operate computer and office equipment as needed
  • Must be able to travel via airlines as needed

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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