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Manager, International Regulatory Affairs

Apply Now Job ID R-335823 Date posted 04/17/2019

Job Description Summary

Job Description

Reporting to the VP, Regulatory Affairs – Preanalytical Systems, this individual contributor role supports the regulatory registration of PAS products worldwide.  Contributes to Global Product Development System (GPDS) Business Plans by assessing regulatory requirements in various international markets for products under development. Such assessments may influence decisions on where and when to launch new products. Collaborates with associates outside the US to achieve rapid worldwide registration of PAS products by providing all documents needs for such efforts.  Supports continued registration of marketed products on a worldwide basis.  Standardizes processes and procedures throughout all of PAS International Regulatory Affairs and works with Corporate International Affairs on process improvements to streamline registration request completion.

This position does not offer relocation assistance.

  • Establishes strategy and manages international registration activities for PAS products.
  • Contributes to GPDS Business Plans by assessing regulatory requirements in various international markets for products under development.
  • Collaborates with worldwide Regulatory Affairs and Business Leads to achieve rapid worldwide registrations.
  • Supports continued registration of marketed products on a worldwide basis.
  • Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
  • Participates in interactions/negotiations with ex-U.S. regulatory agencies when needed.
  • May manage one or more associates or contractors to handle registration requests and associated documentation, including U.S. FDA Export Certificates.
  • Monitors regulatory developments affecting PAS products and communicates emerging opportunities and concerns to stakeholders, including those on product development teams.
  • Designs and implements training on international registration issues for the RA function and for business stakeholders (e.g., Marketing, Sales, Medical Affairs, and R&D).
  • Represents PAS in external activities, including trade associations and professional organizations.
  • Identifies and implements improvements in product registration processes and standardizes processes throughout all of PAS International Regulatory Affairs.
  • Participates in one or more corporate-wide workgroups to address specific international registration issues.
  • Carry out the above tasks with minimal supervision.

Education

  • B.S. degree or higher in a technical discipline, preferably in engineering, bioengineering, biology, chemistry, or computer science.

Certifications

  • RAPS Certification preferred

Experience

  • A minimum of 3 years Regulatory Affairs experience in medical device companies, preferably including experience in Regulatory Affairs related to in vitro diagnostic devices.

Knowledge/Skills

  • Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
  • Ability to communicate and interact effectively across all levels, disciplines, and regions.
  • Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
  • Demonstrated success in supporting both new and existing product registrations.
  • Demonstrated success in preparing, filing, and completing regulatory submissions/dossiers.
  • Experienced in meeting with, making presentations to, and negotiating with leadership and/or regulators.
  • Demonstrated success in developing strong working relationships with external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.
  • Comprehensive knowledge of regulations applying to medical devices and in vitro diagnostic devices in the U.S., EU, Canada, Japan, Asia Pacific, and Latin America.
  • Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)
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