Manager, Regulatory Affairs
2560 Orchard Parkway
San Jose, CA 95131
Job Title: Manager, Regulatory Affairs
Reports to: Senior Manager, Quality Assurance
FLSA Class: Exempt
*Pay Scale: $145k - $155k
Learn more about our company and how we support you:
Takara Bio USA (TBUSA) empowers life science discovery. We bring innovation and inspiration to every scientist - promoting discoveries that improve health and the environment. We hold values that all employees and prospective candidates should demonstrate: Innovation, Teamwork, Integrity, Respect, Growth, Diversity and Quality. We value helping employees develop their skills and you will be part of this journey!
At Takara Bio, we know that every experimental decision has an impact. Choices matter, from design to data analysis. We create best-in-class products that get the job done. In your hands, what do those research reagents and kits create? Something powerful: knowledge, understanding, and—often—hope! Together we can improve the human condition through biotechnology…and That's Good Science!
How this role drives the company forward:
The Manager, Regulatory Affairs is responsible for leading regulatory strategies, executing compliance tasks and managing relationships with external and internal stakeholders.
The Manager, Regulatory Affairs is an on-site role located in San Jose, CA.
How you will make an impact:
In this role, you will represent TBUSA in pivotal interactions with regulatory authorities and relevant stakeholders. You will assess regulatory requirements and develop strategies or plans for submissions to regulatory agencies related to the approval of new IVDs and/or medical devices into the worldwide market. You will provide sound guidance, instructions, and regulatory interpretations to internal and external staff to help achieve clearance, approval, or registration of TBUSA products with desired claims.
What will you do:
Responsible for leading regulatory submission tasks throughout the organization and execution per regulatory and business requirements.
Document regulatory strategies for product submissions and prepare submission documents as necessary for assays and/or instrumentation – specifically for USA, Europe, and Japan.
Serve as the subject matter expert on global regulations and coordinates resolution using internal resources, regulatory agencies, and outside consultants as needed.
Assist the company in achieving its business goals by analyzing regulatory requirements, developing sound approaches to resolve issues, and delivery of regulatory solutions to project teams and external partners.
Interpret and apply regulatory requirements to business practices and effectively provide regulatory input, advice, and guidance to the organization and its affiliates.
Support internal, regional, and global teams to drive quality and regulatory projects and initiatives.
Perform risk and regulatory assessment of new products pre and post launch and reassess risk for changed products.
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, and attend educational meetings as necessary.
Conduct trainings and/or communicate regulations to technical functions within the organization to enhance team's knowledge of working in a regulated environment.
Assist in the creation, update, and maintenance of internal policies and procedures for the Quality Assurance department.
Oversee processes involved with maintaining annual licenses, permits, and registrations.
Function independently as a decision-maker on regulatory issues and ensure that deadlines are met.
This position has supervisory responsibilities.
How will you get here?
B.S. degree with a Regulatory Affairs certification or an advanced degree in a scientific discipline.
Minimum of 5 years’ regulatory affairs experience in the IVD, medical device, or bio/pharma industry is required.
Must have prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions and international registrations.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of medical devices.
Working knowledge of current and evolving state, federal and international regulations, and procedures relevant to the approval of medical devices (i.e.: FDA, QSR, ISO, USDA, IVDD/IVDR, CMDR, PMDA, and other worldwide regulations as appropriate).
Working knowledge of CLIA certification desired, CLIA lab experience is a plus.
Direct and positive experience in communicating with Regulatory Authorities and partners.
Ability to work on assignments of moderate to complex scope where independent action and high degree of initiative is needed in resolving problems, developing recommendations, and determining appropriate action is required.
Ability to communicate and interact effectively across all levels, subject areas, and regions.
Must possess a high degree of accuracy and attention to detail.
Hands-on, action-oriented, and able to manage and implement multiple projects effectively.
Proficient with applicable database and compliance software, MS Office Suite or similar software.
A few other details:
The position may be required to handle hazardous materials (return shipments). Hazardous material handling and chemical hygiene training is expected and will be provided.
Takara Bio USA, Inc. does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Information about pay scale may change as market trends are analyzed and/or as applicants are evaluated throughout the hiring process dependent on knowledge, skills, abilities, and geographical location.