Regulatory Affairs Specialist, International

Talent Acquisition Team•Caledonia, MI

8d•Hybrid

About The Position

In this position, you will have the opportunity to prepare and submit regulatory filings for U.S. and international markets, including 510(k)s, STED files, Design Dossiers, and Rest-of-World documentation, under the guidance of senior RA staff. You will develop, organize, and maintain product Summary Technical Documentation (STED) to support global registration activities. You will coordinate international registration activities on behalf of customers and global distribution partners. You will review quality records, preclinical data, and clinical materials to verify completeness and accuracy in support of regulatory submissions. You will manage routine annual regulatory requirements, including FDA establishment registration updates, Canadian device license renewals, FURLS listings, and state license maintenance. You will support Notified Body audit preparation by compiling documents, organizing files, and tracking follow-up actions to closure. You will maintain ISO and CE certification documentation to ensure all internationally marketed devices are accurately represented. You will review labeling, IFUs, promotional materials, and marketing content for regulatory compliance and escalate identified issues to senior team members. You will contribute to New Product Development by researching product classifications and compiling documentation to support applicable regulatory pathways. You will collaborate with R&D and sustaining engineering teams to review protocols and technical reports, and help identify regulatory documentation needs. You will identify potential regulatory concerns and communicate them to senior RA staff for guidance and resolution. You will participate in risk management and post-market surveillance activities, including data collection, documentation, and regulatory reporting. You will gather information and assist in the preparation of adverse event and vigilance reports in accordance with applicable requirements and timelines. You will monitor global regulatory updates and standards changes, and help maintain current internal regulatory libraries and tracking tools. You will maintain documentation for Authorized Representatives and In-Country Caretakers across international markets. You will review QA/RA-related customer and distributor contract sections for regulatory accuracy and coordinate with senior RA staff for final approval. You will support regulatory activities associated with product notifications, advisory notices, and recall management. You will gather data and assist in evaluating the regulatory impact of proposed preclinical, clinical, and manufacturing changes. You will contribute to change control processes by collecting, organizing, and maintaining required regulatory documentation throughout the product lifecycle.

Requirements

Bachelor’s degree in a scientific, technical, or related field required
2–5 years of experience in a regulated industry, preferably medical devices or combination products
Understanding of ethical standards governing the regulatory profession, clinical research, and the regulatory submission process
Familiarity with regulatory history, guidelines, policies, and applicable product laws across domestic and international jurisdictions
Working knowledge of international submission and registration requirements, including GxP frameworks (GCP, GLP, GMP) and applicable regional regulations
Basic familiarity with promotion, advertising, labeling requirements, and the EU Medical Device Regulation (EU MDR)
Strong technical writing skills with the ability to produce clear, accurate regulatory documents
Effective verbal and written communication skills, including the ability to present information clearly to cross-functional teams
Collaborative team player with experience participating in or facilitating cross-functional meetings
Solid research and analytical skills with the ability to organize and summarize complex regulatory information
Ability to read, interpret, and apply legal, technical, and scientific documents relevant to regulatory activities
Capable of managing routine tasks independently while seeking guidance on complex or ambiguous regulatory situations
Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment
Proficiency in Microsoft Office Suite
Willingness to work outside standard business hours as needed to support international teams and global customer requirements

Nice To Haves

M.S. or M.B.A. is a plus
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus
Advanced degree may be considered in lieu of years of experience

Responsibilities

Prepare and submit regulatory filings for U.S. and international markets, including 510(k)s, STED files, Design Dossiers, and Rest-of-World documentation, under the guidance of senior RA staff.
Develop, organize, and maintain product Summary Technical Documentation (STED) to support global registration activities.
Coordinate international registration activities on behalf of customers and global distribution partners.
Review quality records, preclinical data, and clinical materials to verify completeness and accuracy in support of regulatory submissions.
Manage routine annual regulatory requirements, including FDA establishment registration updates, Canadian device license renewals, FURLS listings, and state license maintenance.
Support Notified Body audit preparation by compiling documents, organizing files, and tracking follow-up actions to closure.
Maintain ISO and CE certification documentation to ensure all internationally marketed devices are accurately represented.
Review labeling, IFUs, promotional materials, and marketing content for regulatory compliance and escalate identified issues to senior team members.
Contribute to New Product Development by researching product classifications and compiling documentation to support applicable regulatory pathways.
Collaborate with R&D and sustaining engineering teams to review protocols and technical reports, and help identify regulatory documentation needs.
Identify potential regulatory concerns and communicate them to senior RA staff for guidance and resolution.
Participate in risk management and post-market surveillance activities, including data collection, documentation, and regulatory reporting.
Gather information and assist in the preparation of adverse event and vigilance reports in accordance with applicable requirements and timelines.
Monitor global regulatory updates and standards changes, and help maintain current internal regulatory libraries and tracking tools.
Maintain documentation for Authorized Representatives and In-Country Caretakers across international markets.
Review QA/RA-related customer and distributor contract sections for regulatory accuracy and coordinate with senior RA staff for final approval.
Support regulatory activities associated with product notifications, advisory notices, and recall management.
Gather data and assist in evaluating the regulatory impact of proposed preclinical, clinical, and manufacturing changes.
Contribute to change control processes by collecting, organizing, and maintaining required regulatory documentation throughout the product lifecycle.
Maintain working knowledge of the quality management system, including the quality manual, quality policy, and applicable procedures and work instructions.
Communicate quality system status and improvement opportunities to the VP of QA/RA as directed.
Support the implementation and maintenance of the quality management system in accordance with FDA regulations, ISO 13485, MDSAP jurisdictions, and all other applicable requirements.
Assist in reviewing and maintaining quality system documentation and policy to ensure ongoing accuracy.
Demonstrate understanding of and adherence to the quality policy, and support awareness efforts across the organization.