Manager, International Regulatory Affairs
Reporting to the International Regulatory Affairs Senior Manager, this people manager role supports the regulatory registration of Integrated Diagnostic Solutions (‘IDS’) Specimen Management (‘SM’) 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 IDS SM 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 IDS SM International Regulatory Affairs and works with Corporate International Affairs on process improvements to streamline registration request completion.
- Establishes strategy and manages international registration activities for IDS 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-US. Regulatory agencies when needed.
- Directs one or more associates or contractors to handle registration requests and associated documentation.
- Monitors regulatory developments affecting IDS 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 stake holders (e.g., Marketing, Sales, Medical Affairs, and R&D).
- Represents IDS in external activities, including trade associations and professional organizations.
- Identifies and implements improvements in product registration processes and standardizes processes throughout all of IDS International Regulatory Affairs.
- Participates in one or more corporate-wide workgroups to address specific international registration issues.
- Interprets ex-US regulations and guidance documents and is able to communicate impact back to the business.
- Manages the iRAOP for IDS including the coordination and chairing of iRAOP calls with the regions and countries.
Manages and coordinates the electronic Global Product Submission (eGPS) database with an in depth understanding of advanced technical/scientific principles that relate to multiple diverse and complex product lines or manufacturing processes to:
- Ensure that the most recent, reliable source documents for product registrations are linked, scanned and/or uploaded into the database
- Respond to and track the additional information requests (AIRs) submitted by the international regional RA partners
- Provide training as a Super User
- Develops and maintains departmental procedures (SOPs & Work Instructions) for international product registrations.
- Identifies and implement continuous process improvements
- Independently coordinatse and collecst specific registration information with R&D, Manufacturing, QA, Medical Affairs, and other applicable departments as necessary. Coordinate timely preparation of request for Certificates for Foreign Government, Certificates of Manufacturing and Free Sales, and Certificates for Exportability. Monitoring and collecting/compiling the impact assessments of product changes (ACRs) for outside the US.
- Carries out the above tasks with minimal supervision.
- B.S. degree or higher in a technical discipline, preferable in engineering, bioengineering, biology, chemistry, or computer science.
- Minimum of 3 years’ Regulatory Affairs experience in medical device companies, preferably including experience in Regulatory Affairs related to in vitro diagnostic devices.
- People Managerial experience is required.
- Experience supporting product development and/or product support projects.
- Demonstrated ability to effectively communicate both verbally and in writing.
- Successful history of handling multiple projects, and prioritize activities and managing deadlines.
- Experience maintaining confidential information at appropriate levels within an organization.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
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Job posted: 2020-09-22