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Associate Medical Device Labeling Jobs in Georgia

Artivion

Senior Medical Writer

Kennesaw, GA · On-site

Company Overview Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device ... Support preparation of product IFUs and assist with labeling and labeling changes (including ...

CryoLife

Senior Medical Writer

Kennesaw, GA · On-site

Company Overview Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device ... Support preparation of product IFUs and assist with labeling and labeling changes (including ...

SRG Government Services

Warehouse Associate

Atlanta, GA · On-site

$22/hr

Responsible for outbound shipping, included packing, labeling and shipping. * Maintain all assigned ... CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical ...

ICON

Senior Clinical Research Associate

Atlanta, GA · On-site +1

Senior Clinical Research Associate - Cardio (Smartpulse A-fib) - All Regions ICON is a global ... The ideal candidate will have cardiovascular medical device monitoring experience- however, complex ...

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All JobsAssociate Medical Device Labeling JobsAssociate Medical Device Labeling Jobs in Georgia

Associate Medical Device Labeling information

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 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 are the most commonly searched types of Medical Device Labeling jobs in Georgia?

The most popular types of Medical Device Labeling jobs in Georgia are:

Associate Medical Device Labeling jobs near you

Senior Medical Writer

Artivion

Kennesaw, GA • On-site

Full-time

Re-posted 6 days ago

Artivion rating

8.7

Company rating: 8.7 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Responsibilities: 

  • Support product line compliance to US and International regulations and standards as applicable
  • Writing clinical regulatory documents including annual reports, study summaries, and other study rationales.
  • Support clinical requirements for regulatory submissions and maintenance.
  • Coordinating company deliverables such as but not limited to the CEP, CER, PMCF activities and SSCP process for MDR compliance
  • Collaborate with other departments to work as a team to accomplish tasks
  • Effectively communicate timelines and hold team members accountable to agreed upon timelines required for project dates.
  • Conduct literature reviews and write research summaries related to product line.
  • Support preparation of product IFUs and assist with labeling and labeling changes (including receipt of applicable translations).
  • Effectively present and share clinical data.
  • Develop and maintain any applicable clinical research databases as necessary.
  • Generate interim analysis, investigator meeting slides, and final clinical study reports.
  • Communicate with physicians, vendors, and other medical experts.
  • Report on adverse events, complaints, and failures associated with the product line identified through the writing process
  • Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
  • Oversee project timelines, budgets, budget change forms, accruals, and monthly reports associated with vendor supported projects
  • Generate clinical study documents including but not limited to: protocols, investigational plans, informed consent forms, handouts, SOPs, and status reports.
  • Liaison between Artivion, investigational sites, and CROs (as applicable) to coordinate and document final reports and publications.
  • Other assigned responsibilities (including previously identified tasks being performed at a higher level than one’s current title).
  • Support the development of clinical regulatory documents to support product maintenance.

Qualifications:

  • Minimum 3-4 years’ experience writing within the medical/biomedical industry.
  • BS or MS degree in biological science, epidemiology, engineering, statistics, or other science related field.
  • Knowledge of regulatory requirements relative to medical devices including Clinical Evaluation Reports and Post Market Requirements
  • Ability to write and edit quality medical abstracts, white papers, manuscripts, and other educational materials.
  • Experience with literature searches and analysis.
  • Demonstrate computer skills (spreadsheet, relational databases).
  • Excellent written and oral communication skills.
  • Excellent interpersonal skills.
  • Ability to manage multiple projects.

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