Regulatory Affairs Specialist

Job Summary:

This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation.

Job Details:

Associate is responsible to follow requirements of applicable national and international regulations.

Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.

Participates on product design teams and verifies compliance with design control requirements and procedures.

Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.

Maintain documentation and a historical record for projects and provide management with updated product status.

Maintains current knowledge of Federal USA, Canadian, MDR and other International regulations pertaining to legal distribution of medical products. Stays abreast of Regulatory Agency updates including new policies and guidance’s.

Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.

Assists external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status.

Must make a proactive contribution to the overall Regulatory affairs department growth.

Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement.

Develop regulatory strategies for new products with the guidance of Regulatory Management

Performs other job related duties as assigned.

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

Strong organizational skills and time management skills

Knowledge of GLP/GMP requirements

Strong written and oral communication skills

Knowledge of FDA, EU, MHLW, TGA and other International requirements

Knowledge of product labeling requirements and standards

Advanced ability for independent work, teamwork, and decision making

Ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.

Ability to analyze data received and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution.

Strong computer skills; MS Office, Adobe Acrobat

Background Experiences

Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline and one year of relevant experience or combination of equivalent education, background, experience and training

Experience in a medical device quality assurance environment preferred

Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.

Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.