Senior Regulatory Affairs Specialist

Tosoh Bioscience, Inc.

115d

About The Position

Under the direction of the Sr. Manager Regulatory Affairs, the Sr. Regulatory Affairs Specialist will draft and file documentation and submission materials in support of global 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, including submissions, product registrations, and execution of any post market commitments as required. Regulatory review of the product labeling, promotional material and e-labeling forms an integral part of this role. Sr. Regulatory Affairs Specialist will report to the Sr. Manager Regulatory Affairs.

Requirements

• 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.

Nice To Haves

• Regulatory Affairs Certification preferred (e.g., RAPS)

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree