Regulatory Affairs Associate

Job Title: Regulatory Affairs Operations SpecialistJob Description

This role focuses on designing, developing, and implementing international addendum labeling, including Instructions for Use, import labels, and country-specific labeling for medical devices. You will work closely with Regulatory Affairs specialists, international regulatory affiliates, and product owners to ensure that all labeling meets global regulatory requirements, supports post-approval changes, and aligns with internal brand and quality standards.

Responsibilities

• Design, develop, and implement international addendum labeling, including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling for medical devices.

• Introduce and support a centralized process for post-approval addendum labeling activities across the medical device portfolio.

• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop robust labeling strategies.

• Fulfill international addendum labeling requests, ensuring conformance with country-specific requirements, country-of-origin rules, and international certification marks.

• Ensure all labeling complies with applicable regulatory requirements, standards, and internal brand and design guidelines.

• Work effectively with cross-functional teams to develop labeling that meets FDA and international regulatory agency requirements while aligning with internal design and product requirements.

• Manage large-scale labeling change projects, including planning, coordination, and execution of multiple concurrent labeling initiatives.

• Communicate labeling projects, priorities, and status updates across the division and plan project timelines to meet multiple deadlines.

• Complete assessments for projects to identify the scope, impact, and risks related to labeling changes.

• Understand and evaluate the impact of changing regulations and product requirements on labeling and recommend appropriate updates.

• Prepare and complete forms, coordinate redlines, review content, and submit labeling packages to the labeling team for development.

• Coordinate labeling release activities 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 the PLPM team to program addendum labeling.

• Troubleshoot labeling-related issues, clearly communicate their impact, and propose practical solutions.

• Monitor changing regulations, emerging regulatory issues, and trends in global markets, and translate new requirements into the quality system.

• Ensure all labeling activities comply with internal procedures, quality system requirements, and external regulatory expectations.

• Stay updated on changes in regulatory requirements and implement necessary updates to internal procedures and processes.

• Drive quality system process improvement initiatives, such as change management enhancements related to labeling and documentation.

• Maintain accurate and up-to-date records of labeling changes, approvals, and associated documentation.

• Track labeling change requests across multiple projects and ensure timely completion and documentation.

• Provide documentation and support for internal and external audits related to labeling and Regulatory Affairs operations.

• Support the preparation of KPI dashboards and maintain ongoing visibility into key performance indicators related to labeling operations.

• Collaborate effectively with colleagues at all levels, demonstrating strong communication, organization, and time management skills.

• Handle multiple workstreams simultaneously while maintaining high accuracy and attention to detail in all labeling and documentation tasks.

Essential Skills

• Bachelors degree in Regulatory Affairs, Biomedical Engineering, or a related field.

• Minimum of 4 years of experience in a regulated industry, such as medical devices or similar highly regulated sectors.

• Experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance engineering, and/or regulatory affairs.

• Proven experience in labeling design and development from a regulatory perspective.

• Strong knowledge of regulatory requirements for medical device labeling.

• Experience working with policies and procedures that impact documentation and documentation practices.

• Proficiency in SAP MD and other relevant software systems used for labeling and documentation.

• Proficiency with PC-based tools and Microsoft Office applications.

• Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional and international teams.

• Strong attention to detail and organizational skills, with the ability to maintain accurate records and manage multiple projects.

• Ability to work independently with strong administrative and time management skills.

• Demonstrated ability to troubleshoot issues and drive problems through to resolution.

• Critical thinking skills and the ability to assess the impact of regulatory changes on labeling.

• Ability to handle multiple streams of work simultaneously while meeting deadlines in a regulated environment.

Additional Skills & Qualifications

• Experience with medical device labeling or labeling in a highly regulated industry with international regulatory requirements.

• Familiarity with Adobe Acrobat Pro, SAP, and other content management systems used in labeling and documentation.

• Substantial experience coordinating and executing project activities in a highly regulated industry.

• Experience driving quality system process improvements, including change management initiatives.

• Ability to develop and interpret KPI dashboards and use metrics to improve labeling operations.

• Strong interpersonal skills and the ability to build effective working relationships with internal and external stakeholders.

• Independent, proactive work style with the ability to prioritize tasks and manage competing demands.

Work Environment

This position operates in a professional, highly regulated environment focused on medical device labeling and Regulatory Affairs operations. You will work standard business hours, Monday through Friday from 8:00 AM to 5:00 PM. The role involves frequent collaboration with cross-functional teams, including Regulatory Affairs, international regulatory affiliates, packaging and labeling, and program management. You will regularly use systems such as SAP MD, other SAP-based tools, Microsoft Office, and content management platforms like Adobe Acrobat Pro to manage labeling, documentation, and project activities. The work emphasizes accuracy, documentation discipline, and compliance with global regulatory and quality system requirements in an office-based setting.

Job Type & Location

This is a Contract position based out of Santa Clara, CA.

Pay and Benefits

The pay range for this position is $40.00 - $43.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Santa Clara, CA.

Application Deadline

This position is anticipated to close on Nov 2, 2026.

Workplace Type

This is a fully onsite position in Santa Clara,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.