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.