Regulatory Affairs Operations Specialist

Cynet Systems•Santa Clara, CA

About The Position

The Regulatory Affairs Operations Specialist will join the Regulatory Affairs Operations team and design, develop, and implement international addendum labeling for medical devices, including Instructions for Use (IFUs), import labels, and country-specific labeling. The role supports a new process to centralize post-approval addendum labeling activities across the full Vascular medical device portfolio and requires regulatory affairs and labeling experience. The specialist will liaise with international Regulatory Affairs local experts and U.S. Regulatory Affairs product owners, while coordinating with cross-functional teams to ensure labeling meets international, FDA, internal brand and design, and product requirements. The position manages labeling strategies and large-scale change projects, assesses project scope and impact, tracks multiple concurrent deadlines, and coordinates the review, submission, programming, and release of labeling packages. It also involves monitoring regulatory changes in international markets, translating requirements into the quality system, maintaining records and metrics, and supporting audits and process improvements.

Requirements

Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
At least 4 years of experience in a regulated industry and in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering, and/or regulatory affairs.
Experience working with policies and procedures that affect documentation and documentation practices.
Proven experience in labeling design and development from a regulatory perspective.
Strong knowledge of regulatory requirements for medical device labeling.
Proficiency in SAP MD and other relevant software systems.
Excellent communication and collaboration skills.
Detail-oriented, with strong organizational skills.
Good people relations and the ability to work independently, with strong administrative and time-management skills.
PC and Microsoft Office experience.
Ability to troubleshoot, think critically, drive problems through resolution, implement mitigations, and handle multiple work streams simultaneously.

Nice To Haves

Experience with medical-device labeling or labeling in a highly regulated industry, including international regulatory requirements.
Familiarity with Adobe Acrobat Pro, SAP, and other content management systems.
Substantial experience coordinating and executing project activities in a highly regulated industry.

Responsibilities

Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop labeling strategies.
Create and design addendum labeling, including IFUs, product labels, import labels, and country-specific labeling.
Fulfill international addendum labeling requests in accordance with country requirements, country of origin, and international certification marks.
Ensure labeling complies with regulatory requirements, standards, internal brand and design requirements, and product specifications, including FDA and international agency requirements.
Independently manage large-scale labeling change projects, communicate priorities across the division, plan timelines, and manage concurrent deadlines.
Assess project scope and impact to labeling and understand the effects of changing regulations and product requirements.
Complete forms, coordinate redline reviews, and submit labeling packages to the labeling team for development.
Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team.
Prepare and submit Universal Addendum Labeling (UAL) SAP packages to PLPM for addendum-label programming.
Troubleshoot issues, communicate their impact, and propose solutions.
Monitor emerging regulatory issues and trends in international markets and translate requirements into the quality system.
Ensure labeling activities comply with internal procedures and regulatory requirements, and implement necessary updates to internal procedures as requirements change.
Drive quality-system process improvement initiatives, such as change management.
Maintain accurate records of labeling changes and approvals, and track labeling change requests across projects.
Provide documentation and support for audits.
Drive preparation of KPI dashboards and monitor formal internal Regulatory Affairs metrics.