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Associate Medical Device Labeling Jobs in California

Labeling Specialist

Cupertino, CA · On-site

$62 - $67/hr

Knowledge of domestic and international medical device regulatory requirements for product labeling and unique device identification (e.g. 21 CFR 801 and EU MDR). * Knowledge of quality management ...

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Experience with medical device labeling or labeling for highly regulated industry and international regulatory requirements. * Familiarity with Adobe Acrobat Pro, SAP, and other content management ...

... associates that reflects positively on the company and is consistent with the company's policies ... preferable in medical device manufacturing · MS Office Suite experience · Knowledge of ...

FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements * Regulatory Affairs ...

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... Associate III and play a direct role in assembling high-quality medical devices in accordance with ... Experience with medical device manufacturing (preferred) * Experience or certification as a trainer ...

FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements * Regulatory Affairs ...

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Associate Medical Device Labeling information

What are some common challenges faced by Associate Medical Device Labeling professionals, and how can they be addressed?

Associate Medical Device Labeling professionals often encounter challenges such as keeping up with evolving regulatory requirements across different countries, ensuring accuracy and clarity in complex technical information, and coordinating input from multiple departments like regulatory affairs, engineering, and marketing. Addressing these challenges involves staying updated on global labeling standards, developing strong attention to detail, and building effective communication and collaboration skills. Leveraging project management tools and regularly participating in training can also help manage these complexities and ensure timely, compliant labeling deliverables.

What are Associate Medical Device Labeling professionals?

Associate Medical Device Labeling professionals are responsible for creating, reviewing, and maintaining the labeling and packaging materials for medical devices. Their work ensures that all product information, instructions, and regulatory warnings are accurate, clear, and compliant with industry regulations. They collaborate closely with regulatory affairs, quality assurance, and product development teams to make sure that labels meet local and international standards. This role is critical in helping ensure patient safety and regulatory approval of medical devices.

What are the key skills and qualifications needed to thrive as an Associate Medical Device Labeling Specialist, and why are they important?

To thrive as an Associate Medical Device Labeling Specialist, you need a strong understanding of regulatory requirements, attention to detail, and experience in technical writing, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document management systems, and knowledge of FDA or EU MDR regulations are typically required. Excellent communication, collaboration, and organizational skills set top performers apart in this position. These skills are crucial to ensure label accuracy, regulatory compliance, and patient safety in a highly regulated industry.
What are the most commonly searched types of Medical Device Labeling jobs in California? The most popular types of Medical Device Labeling jobs in California are:
What cities in California are hiring for Associate Medical Device Labeling jobs? Cities in California with the most Associate Medical Device Labeling job openings:
Labeling Specialist

Labeling Specialist

CYNET SYSTEMS

Cupertino, CA • On-site

$62 - $67/hr

Contractor

Posted yesterday

Be an early applicant


Job description

Job Overview:

Pay Range: $62.16/hr - $67.16/hr

Requirement/Must Have:

  • Bachelor’s Degree, or equivalent experience.
  • 2+ years of medical device labeling experience.
  • Knowledge of domestic and international medical device regulatory requirements for product labeling and unique device identification (e.g. 21 CFR 801 and EU MDR).
  • Knowledge of quality management system requirements such as design change control, document control, requirements, and regulatory approvals.
  • Strong verbal and written communication skills.
  • Excellent interpersonal skills working across multiple divisions.
  • Attention to detail, well organized and time efficient.
  • Ability to multi-task and work independently.
  • Technical writing skills.

Responsibilities:

  • Leads the Instructions for Use (IFU) creation and ensures compliance to global regulatory requirements, completes labeling reviews to verify compliance of labeling, and implements IFU with cross functional teams.
  • Manages marketing claims.
  • Coordinates internal marketing and post-market material review/approval.
  • Establishes systems for physical labeling controls.
  • Maintains labeling in accordance to global standards and regulatory requirements.
  • Provides up-to-date guidance and implementation of evolving global labeling requirements.
  • Coordinates with Regulatory Affairs to incorporate country-specific requirements and translations for international markets.
  • Participates in design and change control processes to update labeling related to new product developments, product changes, or regulatory updates.

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting powerhouse. Proudly recognized as a nationally and locally certified diversity firm, Cynet delivers agile, scalable talent solutions across industries. With an active footprint in all 50 U.S. states and Canada, we support thousands of consultants through our expansive, high-performing recruitment engine operating across North America and Asia—ensuring speed, quality, and consistency in every hire.

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About Cynet Systems

Sourced by ZipRecruiter

Cynet Systems Inc is a staffing and recruiting corporation nestled in Ashburn, VA, USA. Established in 2010, the company operates within the Information Technology and Services sector, specializing in providing effective workforce solutions to different business needs, including IT consulting, direct hire, and contract staffing services. Through the years, Cynet Systems has built an impressive portfolio, going beyond borders and expanding its operations internationally in Canada and India. Rooted in its core values of teamwork, leadership, and commitment, Cynet Systems helps businesses unlock their full potential by providing versatile and competent professionals that perfectly align with their needs. Fueled by their unwavering mission to deliver top-tier talent to businesses worldwide, Cynet Systems garnered various recognitions including SIA's fastest-growing staffing firms and Best Place to Work in Virginia for 2019.

Industry

It services

Company size

501 - 1,000 Employees

Headquarters location

Sterling, VA, US

Year founded

2010

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