Director, Regulatory

Description

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

Senior leadership role responsible for providing direction, guidance and leadership to the Regulatory Affairs department.  The position reports to the Executive Vice President and is responsible for the daily operations of the Regulatory Affairs department as it helps develop and execute regulatory strategies and activities contributing to the commercial objectives of TBI. This position will interface with Tosoh Bioscience Japan and with other TBI departments including Sales and Marketing to coordinate plans and assure efficient operations to meet all applicable regulatory requirements including 21 CFR Part 820, Quality System Regulation, 21 CFR Part 803, Medical Device Reporting, 21 CFR Part 806, Corrections and Removals, ISO 13485, Quality Systems Regulation, Health Canada Regulations and Requirements and Latin American Regulations and Requirements. This position will be responsible for managing and participating in the review of performance data, writing pre-submission communications to FDA, preparation of protocols, and e-Submissions for 510(k) and PMA products. Additionally, this position will be responsible for managing registrations for Latin America and Canada.

Location 

This candidate is required to currently reside in a state in the Eastern Standard Time Zone. 

Reporting Relationships

The Director of Regulatory Affairs reports to the Executive Vice President (EVP) and will have direct reports.

Major Duties and Responsibilities

• Plans with executive management marketing to develop regulatory strategies and ensure implementation, including timely submissions (510(k), PMA, etc.).

• Manage RA department and overall submission process, ensuring the team prepares e-Submission with completed documentation and appropriate forms for new products.

• Prepare documents for CLIA categorization after new analyte clearance.

• Manage engagement and ongoing relationships with the FDA, including managing department preparation of pre-submission correspondence with the FDA to determine all protocols and data collection meets the agency’s needs.

• Mange department review performance data provided by Tosoh Bioscience Japan’s (TBJ) R&D. Ensure departmental process are met and determine completeness and accuracy prior to submission.

• Manage clinical affairs activities and personnel.

• Prepare letters to file for correction and manage related processes for new instrument launches, from preparation to response, and post-assessment.

• Ensure department manages all regulatory documents for International (Latin America and Canada) registration and tenders on a timely basis, including a.) Maintain current registration documentation and ensure that all are up to date, b.) Interface with Product Management to determine new product availability from TBJ, c.) Maintain logs, contacts, and processes for authentication for registration documents.

• Participate in Management Reviews.

• Lead as necessary, internal or external audits and inspections.

• Manage communication and serve as FDA Regulatory Contact/Representative and International ministry of health officials including Canada and Latin America as required.

• Develop and deploy ISO registration and surveillance strategy with Notified Bodies.

• Lead and monitor the ongoing process for creation and maintenance of product design dossier/technical files.

• Maintain an up-to-date knowledge in applicable domestic and international regulations and standards, as well as company products and process technologies.

• Manage the Regulatory Affairs group and conduct performance review and professional development for the Regulatory Affairs group.

Leadership

• Provide leadership, independent expertise, objective assurance, and advisory services designed to add value to the organization, the department, and to executive management.

• Prepare, manage, monitor, and revise department Budget.

• Influence key decision makers through effective communication and active engagement with the Management Team.

• Provide leadership and direction to external consultants as necessary.

• Direct and develop department team, including initiating personnel actions, such as employee hires, evaluations, promotions, transfers, and discharges.

• Mentor, direct, and provide guidance to the department team and other employees.

• Assess employee and company-wide regulatory training needs and conduct, develop, and recommend training as necessary.

• Demonstrate a high standard of work ethics and professionalism to subordinates, peers, and superiors.

• Motivate and interact effectively with the RA department and inter-departmental teams and demonstrate ability to increase efficiencies and performance measures.

• Lead a team of regulatory professionals to accomplish department and company objectives; demonstrate organizational awareness, responsiveness, and ability to organize complex and technical work

Education

• B.S. degree in biology or chemistry, engineering or health sciences.

• M.S. Preferred.

Skills and Qualifications

• 15 years medical device/IVD Regulatory Affairs.

• 5 years of management experience in regulatory affairs.

• Understanding of basic immunochemistry and HPLC chemistry.

• Experience in managing processes of departmental submission to FDA. Prior experience preparing submission documents, including eSub preparation of 510(k) PMAs.

• Desired experience in clinical trial processes.

• Familiarity with Microsoft Word, Excel, PowerPoint, EP Evaluator, and Analyze IT.

• Good written and verbal communication skills.

• Understanding of business-related aspects with regards to confidentiality of corporate affairs.

• Ability to travel as the job requires.

• Knowledge of Latin American registration requirement is a plus.

• Ability to speak Spanish and Portuguese language is a plus.

Physical Requirements

This position requires visits to customer sites which are medical facilities.  These facilities may have certain requirements which Company 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 and/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.

• Frequently performing desk-based computer tasks, including frequent typing

• Occasional travel to meetings and other special events.

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

Qualifications