Senior Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist will report to the Sr. Manager Regulatory Affairs

• Coordinate, compile and submit U.S, and/ or International regulatory submissions, including filing and/or creation of PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
• Develop 510k/ PMA (US) submissions for class II and III in vitro diagnostic medical devices.
• Generate documents and/or oversee generation of documents (pre-clinical and clinical) to be submitted to the US FDA in order to secure approvals to market products in the USA.
• Develop pre-clinical (analytical) and clinical testing protocols for in vitro diagnostic medical devices as defined by US FDA Special Controls or applicable CLSI / internationally harmonized standards.
• Handle multiple submissions and respective timelines (PMA, 510ks).
• Apply advanced regulatory expertise to the evaluation and solution of submission problems and drive product change assessments and define regulatory impact of product changes in global markets.
• Conduct regulatory intelligence/research to assist in preparation of regulatory strategies and plans.
• Review and approve assigned product labeling, advertising, and promotional materials, to ensure full compliance with all applicable and relevant labeling guidelines.
• Participate in cross-functional product meetings and guide teams to provide content for US and/or international submissions.
• Communicate with and maintain productive, constructive relationships with regulatory bodies as required – US FDA, Health Canada, and other in-country regulatory agencies as needed.
• Consult closely with marketing and sales in support of registering products in the desired territories.
• Represent Regulatory Affairs in audits/internal audits and inspections as appropriate.
• Maintain ongoing surveillance and analysis of pertinent in vitro diagnostic medical device regulations to ensure submission requirements world-wide are current and up to date ensuring new or modified requirements are conveyed to the appropriate personnel.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Write, update, and manage regulatory SOPs.
• Mentor and train team members inside Regulatory Affairs and stakeholders outside core teams.
• Perform miscellaneous job-related duties as assigned.
• Uphold and adhere to the Tosoh America culture and guiding principles.

Bachelor’s degree in biology, chemistry, bioengineering or related scientific area

• Minimum of 8 years of IVD Regulatory Affairs experience required.
• Working experience with 510(k) or PMA Submissions required.
• Proficient/knowledgeable in the aspects of regulatory strategy creation, design control, Quality Systems.
• Experience in direct and positive communication with regulatory agencies.
• Experience as RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
• Experience in the balance and application of regulatory requirements.
• Strong oral and written communication skills, as well as the ability to provide scientific presentations.
• Ability to compile data and summarize results.
• Continuous improvement minded, familiar with balancing Quality and the need for efficiency.
• Regulatory Affairs Certification preferred (e.g., RAPS)

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

• 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.

• 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.