Regulatory Affairs Specialist, Latin America (Ivd)

Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.

Summary

Under the direction of the Sr Manager Regulatory Affairs, the Latin AmericaRegulatory Affairs Specialist will draft and file documentation and submission materials in support of Latin American product registrations, assuring compliance to regulations and guidelines and securing timely marketing authorizations according to agreed-upon plans. This position will manage communications with regulatory authorities, market registration holders and distributors to ensure timely registrations, renewals, product change submissions and annual reporting where applicable. The Latin AmericaRegulatory Affairs Specialist also supports the Quality/Compliance team with the execution of any post market commitments and/or reporting requirements as required. Regulatory review of translated product labeling, promotional material, and e-labeling forms an integral part of this role.

Major Duties and Responsibilities

• Act as privileged point of contact with other Tosoh companies, distributors, and registration holders. Lead regular follow-ups with the countries and work closely with Tosoh’s Latin America team and other global functions.
• Coordinate, compile and submit the registration and/or renewal dossiers withing the defined deadlines to our local regulatory contacts based on agreed upon project plans.
• Drive product change assessments and define regulatory impact of product changes in view of country specific requirements. Compile supplements, change notifications, and other country-specific product amendments and ensure appropriate reporting.
• Ensure traceability of country registrations, renewals and approvals and initiate regulatory actions as needed.
• Support development of submissions strategies for class I, II and III in vitro diagnostic medical devices for various Latin American countries considering existing dataset or leverage requirements.
• Manage the generation and maintenance of documentation to be submitted to various governmental regulatory agencies to secure approvals to market products (e.g., authentications, notaries, apostilles of GFGs, FSCs).
• Collaborates with cross-functional teams for preparation of additional data/information requested by regulatory agencies and/or distribution holders and prepares appropriate responses to all requests.
• Participate in cross-functional product meetings and guide teams to provide content for Latin American submissions and/or renewals.
• Communicate with and maintain productive, constructive relationships with distributors, registration holders, and in-country regulatory agencies as applicable.
• Liaise closely with marketing and sales in support of registering products in the desired territories.
• Perform miscellaneous job-related duties as assigned.
• Uphold and adhere to the Tosoh America culture and guiding principles.

Education

• Minimum required education: Bachelor’s degree in biology, chemistry, bioengineering or related scientific area.

Skills and Qualifications

• Minimum of 5 years of IVD Regulatory Affairs experience required.
• Experience with several Latin American countries’ product registration/assessment.
• Experience in negotiating with regulatory authority personnel in in vitro diagnostic areas.
• International product registration experience required.
• Proven ability to interpret in vitro medical device regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR).
• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
• Strong oral and written communication skills, as well as the ability to provide scientific presentations.
• Digital literacy (Excel, PowerPoint, Access, MS Project, Regulatory E-Systems).
• Project management experience highly preferred; experience with prioritizing multiple tasks and driving results.
• Professional level of spoken and written for both English and Spanish is a must. Portuguese is a plus.

Physical Requirements

The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to travel by auto and air, including international. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions

• This position might require visits to customer sites which are medical facilities. These facilities may have certain requirements which TOSOH representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.
• Must agree to provide required immunization records or agree to acquire required immunizations to gain access to customer sites, as required by, customers. You may be required to register at vendor credentialing companies.

Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans