Principal Regulatory Affairs Specialist (Remote)
Company: Terumo Medical Corporation
Posted on: May 11, 2022
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.
Associate is responsible to follow requirements of applicable
national and international regulations.
Analyze data received and prepare documentation for complex
submission which may contain clinical trial data 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.
Acquire and maintain a current knowledge of federal regulations
pertaining to the lawful distribution of products which include
facility registration, device listing, labeling and promotional
Maintain documentation and a historical record for projects and
provide management with updated product status.
Participate in task force groups and industry working groups.
Maintains current knowledge of Federal USA, Canadian, MDR and
International regulations pertaining to legal distribution of
Stays abreast of Regulatory Agency updates including new policies
Interact with production division, federal agencies, industry
organizations, interdepartmentally and external departments at all
levels.Assists external customers by supplying materials and
documentation for US and International product registrations as
well as certification of appropriate US commercialization
Have a proactive contribution approach to the overall Regulatory
Affairs Department growth.
Participate in project performance team meetings on behalf of the
business unit to provide ideas, methods, or processes for
unit/company performance improvement.
Develop global regulatory strategies for high risk products and
lead multidisciplinary project teams.
Provide general regulatory consultation during absence of other
associates and/or manager
Performs other job-related duties as assigned.
Knowledge, Skills and Abilities (KSAs)
Demonstrate the ability to complete regulatory submissions
Advanced ability for independent work, teamwork, and decision
Strong demonstrated ability for decision making based on
interpretations of federal laws, which in many instances are very
general in nature
Strong ability to develop global regulatory strategies for high
risk products and lead multidisciplinary project teams
Ability to lead and mentor Regulatory Affairs associates.
Knowledge of FDA, Canada, EU, MHLW, TGA and other International
Knowledge of product labeling requirements and standards.
Requires a minimum of a 4-year degree in engineering, life
sciences, or similar discipline
Master's Degree in Regulatory Affairs, Life Sciences or Engineering
Requires a minimum of ten years of relevant experience of
increasing responsibility, or combination of equivalent education,
background, and experience.
Experience in a medical device quality assurance environment
Regulatory Affairs Certification preferred.
Experience with 510(k)/IDE/PMA device submissions and/or other
worldwide submissions and clearances required.
Keywords: Terumo Medical Corporation, Portland , Principal Regulatory Affairs Specialist (Remote), Other , Portland, Maine
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