The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
*This position is temporary with a 1-year duration and can be remote.
Primary Objective: The Commercial Regulatory Associate executes regulatory and compliance activities to support achievement of departmental and overall enterprise commercial objectives with particular emphasis on the China and Asia/Pacific regions. Employee to provide dedicated front-line support for commercial/international regulatory efforts with additional focus as a shared-service regulatory resource across Nonin’s product portfolio.
Essential Job Functions:
Partner with local regulatory agents and distributors to assist in preparation, compilation and maintenance of international regulatory registrations to government agencies in global markets with particular emphasis on China and Asia/Pacific regions.
Directly assist with local China registration and manufacturing transfer efforts through engagement with local China distribution partner
Provides dedicated front-line support for commercial/international regulatory efforts and is primarily focused on service of internal/external commercial customers
Participate on project teams to provide regulatory input as assigned. Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization.
Assist with international registration process development, organization and maintenance of current registration dossier and future strategic planning of international submissions
Support the execution of core strategic regulatory submissions (US 510(k), EU MDR CE, TGA, Health Canada) for product approval and/or marketing clearance as needed
Obtain CFGs and co-ordinate document legalization to support international regulatory submissions.
Complete change control documentation for regulatory related product and label changes.
Maintain and organize regulatory affairs files and documentation
Monitor regulatory landscape changes and communicate appropriate information and actions throughout the company
Identify, understand and apply global regulatory regulations to the Nonin business and product portfolio
Assist in implementing department procedures and provide support to RA team, and perform other related duties and assignments as required
Develop and communicate international registration regulatory requirements to product development teams and work closely with the team(s) to assure compliance with and understanding of all regulatory strategies
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
Working ability with MS office programs.
Ability to manage multiple projects and priorities
Ability to communicate and collaborate effectively as a shared-service resource across functions and business groups in matrix organization environment
Masters degree in Regulatory Affairs or equivalent life sciences discipline
Experience in preparing regulatory submissions and associated documents legalization
Fluent in Mandarin and English
Ability to sit, and/or stand for 8 hrs/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.
Internal Number: 2020-1390
About Nonin Medical
Nonin Medical invented finger pulse oximetry and is a global leader in developing highly accurate noninvasive medical monitoring solutions that improve the quality of people's lives. Technology driven, we provide pulse and cerebral oximeters, capnographs, sensors, OEM/eHealth, and veterinary solutions that meet customers'? needs today and tomorrow.
Nonin Medical is headquartered in Plymouth, Minnesota, USA, and has an additional customer service center in Amsterdam, the Netherlands. We sell our products to clinicians and consumers in more than 125 countries and have more than 200 OEM partners worldwide.