Regulatory Affairs Specialist

Description General Position Summary Responsible for promoting awareness and adherence to regulatory requirements for the

Company's products and services, ensuring compliance with domestic and international regulations through the most efficient means.

Collaborates with various internal departments, including Quality, Engineering, R&D, Customer Operations, Sales, and Marketing, as

well as external stakeholders such as customers and suppliers, throughout pre-production, production, and post-production phases.

Develops and implements procedures and practices in accordance with applicable regulations, maintaining the company's quality

system policies, procedures, and processes. Offers recommendations, contributions, and support for monitoring regulations,

standards, and system implementation. Contributes to all aspects of the Quality Systems and Validation Department. The Regulatory

Affairs Specialist guides the internal team through intricate domestic and international regulatory landscapes, working closely

with external government and regulatory authorities and diverse internal stakeholders. Emphasizes attention to detail and

technical expertise to ensure products meet regulatory requirements before distribution and throughout the device's lifecycle,

actively participating in the completion and maintenance of regulatory approvals and clearances for assigned products . Essential

Job Functions Regulatory Affairs Specialist Activities Orchestrates the coordination and preparation of document packages and

dossiers for regulatory submissions within and beyond the U.S. Actively engages in project teams, contributing regulatory

strategy, timelines, and deliverables. Manages global regulatory submissions and ongoing responsibilities, ensuring thorough

reviews of changes to ensure compliance with new standards. Supports the formulation of a global regulatory strategy for

post-market changes, encompassing aspects like design, manufacturing, and labeling. Assists in GUDID submissions. Represents the

regulatory function in manufacturing and product development teams, providing regulatory insights for product lifecycle planning.

This involves: Strategizing and presenting alternatives for meeting regulatory requirements, both within regulatory affairs and

cross-functionally. Resolving conflicts between regulatory requirements and development issues. Escalating complex situations to

management for guidance and training opportunities. Overseeing documentation packages for submission to global regulatory

agencies. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Assisting in

interactions with regulatory agencies, including submission review and on-site audit support (e.g., FDA inspections for future

510(k)s, IVDR audits related to CE marking design dossiers and technical documentation). Providing guidance on regulatory

requirements is essential for contingency planning. Monitoring proposed and current global regulations and guidance, assessing

their impact on assigned projects, and proposing suggestions for leveraging regulatory updates to expedite the approval process.

Reviews labeling content, product and process changes, and product documentation to ensure compliance, consistency, and accuracy

with regulatory requirements. Collaborates with cross-functional teams to define the scope and assess strategies for managing the

entire product lifecycle, including pre-market development and post-market changes. Applies design control principles and

regulatory knowledge to guide teams through successful regulatory reviews. Assists in developing regional regulatory strategy and

adapts strategies based on regulatory changes for medical devices. Anticipates and navigates regulatory obstacles based on

information from international agencies and trends in the regulatory environment. Determines and communicates submission and

approval requirements, monitoring applications under regulatory review. Assists in evaluating proposed preclinical, clinical, and

manufacturing changes for regulatory filing strategies. Maintains annual licenses, registrations, and listings. Assists with

document legalization for foreign country registrations. Ensures compliance with product post-market approval requirements.

Reviews regulatory aspects of contracts and assesses external communications relative to regulations. Assists with label

development and reviews for compliance before release. Participates in determining goals and objectives for projects. Exercises

judgment in selecting innovative, practical methods to achieve problem resolution. Assists with required activities and electronic

submissions for Medical Devices Reporting (MDR/MDVR), product recalls, field corrective actions, product holds, and health hazard

evaluations. Coordinates meetings with the Cross-Functional Team to finalize the decision-making process and follows up to ensure

time-sensitive pending tasks are completed accordingly. Assists in preparing, reviewing, and maintaining Design History Files

(DHFs), Device Master Records (DMRs), Technical Documentation packages (for CE Marking), and other documents and activities for

new product development and regulatory submissions. Collects, evaluates, and summarizes information for reporting to management to

assist with decisions regarding the suitability and effectiveness of the quality management system. Plans, coordinates, and

prepares a variety of reports, surveys, research information, and special informational requests made by management. Participates

in the validation of equipment, instruments, facilities, utilities, software, processes, and other validation activities related

to regulatory functions. Exercises independent judgment and decision-making on complex issues related to job duties, working under

minimal supervision. Uses independent judgment requiring the analysis of variable factors to determine the best course of action.

Performs special projects and other related duties as assigned by management. Authority & Reporting Activities Authorized to

control (stop) further processing or shipment of products and services which do not meet regulatory requirements, company

standards or customer requirements. Authorized to direct the Company personnel in matters concerning regulatory compliance of the

Company’s products and services, as per quality policy. Authorized to lead and introduce regulatory requirements and mechanisms

for implementation and preventive activities. Authorized to lead and review engineering change requests and document change

requests and to reject the requests that do not meet regulatory requirements. Authorized to issue and review Investigation, CAPAs

and SCARs as it relates to regulatory concerns. Authorized to issue and review deviation reports. Authorized to coordinate

activities with external Market Authorization Holder (MAH) representing Sakura Finetek Authorized to coordinate and submit reports

to other Sakura entities on behalf of SFA QA/RA department. Authorized to review and provide feedback to other Sakura entities on

their RA establishment in accordance with FDA requirements. Other Activities Assists in business related activities of Sakura

Finetek USA as needed. Essential Job Requirements Education BA/S in Science/Engineering from an accredited institution or

equivalent combination of education and experience. RA Certification is a plus (such as RAC from the Regulatory Affairs

Professionals Society) Experience & Minimum Qualifications Minimum of 3 years of experience in the medical device field, with at

least 1 year of Regulatory Affairs experience within Medical Devices. Demonstrated ability to lead scientific arguments and apply

analytical and logical reasoning. Some experience in preparing domestic and international product submissions is required.

Preferred completion of coursework, seminars, and/or formal government and/or trade association training. Knowledge and

understanding of global regulatory requirements for new products or product changes. Strong problem-solving, organizational,

analytical, and critical thinking skills. Excellent written and verbal communication skills, as well as interpersonal relationship

skills. Interpersonal skills to professionally interact with all organizational levels. Self-directed prioritization skills to

manage competing priorities in a fast-paced environment. Ability to work in a team environment, including inter-departmental teams

and representation of the organization on specific projects. Capable of building productive internal/external working

relationships. Strong attention to detail. Working knowledge of QSR820, IVD Regulation, ISO 13485, and Design Controls.

Familiarity with MDSAP (Medical Device Auditing Program) is preferred. Proven track record of success in a matrixed,

cross-functional environment. Preferential knowledge of Regulatory history, guidelines, policies, standards, practices,

requirements, and precedents; Regulatory agency structure, processes, and key personnel; Principles and requirements of applicable

product laws; Submission/registration types and requirements; Principles and requirements of promotion, advertising, and labeling;

Domestic and international regulatory guidelines, policies. Experience in leading regulatory document submissions such as

e-MDR/Recall, and direct interactions with regulatory agencies. Excellent knowledge and skills in the use of advanced personal

computer productivity programs for word processing, spreadsheets, database manipulation, and flow charts. Exposure to a broad

spectrum of fabrication processes is desired, including industrial manufacturing, machining, tooling and fixtures, and assembly of

electronics and electro-mechanical components. Excellent analytical and problem resolution skills related to electro-mechanical

products and manufacturing processes. Physical Requirements & Working Environment Ability to communicate orally and in writing;

able to express thoughts and concepts diplomatically, both technically and administratively. Extensive interfaces with all

organizational levels within the company and with regulatory agencies. Requires frequent sitting, standing, climbing stairs and

occasional extended work hours. Must be able to occasionally lift and/or move up to 15 pounds. Occasionally requires the wearing

of protective safety equipment. Requires periods of prolonged mental and visual concentration for reading, data analysis, and

preparation of reports. Ability to read and analyze hard written copy and information on a computer screen. Ability to

successfully respond to multiple work pressures. Ability to communicate verbally in person and using a phone. Ability to listen

for understanding and assist in problem solving. Must be able to occasionally travel to other Sakura facilities. Sakura Finetek

USA, Inc. is an Equal Opportunity/Affirmative Action employer.  All qualified applicants will receive consideration for employment

without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability,

protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.” The above description

identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions

and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable

accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information

contained herein is subject to change at the company's discretion.