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Associate Medical Device Labeling Jobs in Pennsylvania

Exalta Group

Labeling Specialist

Bethlehem, PA · On-site

This position is a subject matter expert in global medical device labeling, regulations and requirements and is responsible for planning, developing and executing labeling documentation and product ...

New

CYNET SYSTEMS

Senior RA Specialist

West Chester, PA · On-site

$52 - $57/hr

Review device labeling, including all graphic material. * Prepare export certificates, medical device listings, and annual establishment registrations for submission to the U.S. Food and Drug ...

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Associate Medical Device Labeling information

What are some common challenges faced by associate medical device labeling, 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 is an associate medical device labeling?

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?

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 Pennsylvania? The most popular types of Medical Device Labeling jobs in Pennsylvania are:
What cities in Pennsylvania are hiring for Associate Medical Device Labeling jobs? Cities in Pennsylvania with the most Associate Medical Device Labeling job openings:
Associate Medical Device Labeling jobs near you

Labeling Specialist

Exalta Group

Bethlehem, PA • On-site

Full-time

Posted 2 days ago

New

Job description

This position is a subject matter expert in global medical device labeling, regulations and requirements and is responsible for planning, developing and executing labeling documentation and product labeling. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes. This position will help EXALTA Group maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.


Responsibilities:

  • Develops, edits, reviews and processes labeling documentation and medical device labeling following company procedures, including translation management. Labeling documentation and labeling to include product labels, instructions for use (IFUs), patient leaflets, implant cards, summary of safety and clinical performance (SSCPs), etc.
  • Ensures labeling documentation and labeling is professional, readable and compliant with applicable global regulations, directives, standards and guidance requirements.
  • Works with cross functional project teams to perform GTIN allocation.
  • Assist with GUDID and EUDAMED data maintenance and submissions.
  • Investigate and resolve internal audit findings and external audit findings related to labeling non-conformities.
  • Support internal and external audits specific to labeling processes and released labeling documentation and labels.
  • Monitor global labeling regulations, directives, standards and guidance requirements for changes in labeling requirements, perform gap assessments where required.
  • Write and update standard operating procedures and work instructions to maintain compliance with applicable labeling regulations, directives, guidance, and standards.

Core Competencies:

  • Medical Terminology
  • Strong understanding of regulations and guidelines related to medical devices and quality systems including: 21 CFR 820; MDD 93/42/EEC; MDR 2017/745; and ISO 13485
  • Excellent communication skills, both written and oral
  • Strong computer skills, project management skills, problem solving skills, and a high attention to detail
  • Ability to work under pressure and with cross-functional teams
  • Project management skills

Education/Experience Required:

  • Minimum of 2 years experience in regulatory affairs or quality systems
  • BA/BS in scientific discipline or equivalent experience


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