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Freelance Medical Device Labeling Jobs in Wisconsin

Director of Regulatory Affairs

Madison, WI · On-site

$151K - $199K/yr

Our client is a growing medical device company developing advanced wound care technologies with ... Provide regulatory guidance across product lifecycle, including R&D, clinical, labeling, and ...

WI · On-site

$152 - $197/hr

... medical device and/or pharmaceutical products * Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling ...

WI · On-site

$200 - $230/hr

... Labeling, Promotion Compliance & Scientific Messaging, and International regulatory). REQUIRED ... Accredited Bachelor's Degree * 10+ years experience within a pharmaceutical, medical device, and/or ...

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Showing results 41-60

Freelance Medical Device Labeling information

What is freelance medical device labeling?

Freelance medical device labeling involves independent professionals who create, review, and manage the labels and instructions that accompany medical devices. These labels must meet strict regulatory requirements to ensure patient safety and regulatory compliance. Freelance specialists may work with manufacturers to develop compliant packaging, user manuals, and product inserts for various markets. They need to be knowledgeable about international regulations and guidelines, such as those from the FDA or the European MDR. This role often requires attention to detail, regulatory expertise, and clear communication skills.

What are the key skills and qualifications needed to thrive as a freelance medical device labeling specialist?

To thrive as a Freelance Medical Device Labeling Specialist, you need expertise in regulatory requirements, medical terminology, and technical writing, often supported by a background in life sciences or regulatory affairs. Familiarity with labeling management systems, document control software, and knowledge of FDA, EU MDR, or ISO standards is typically required. Attention to detail, strong organizational skills, and clear communication are essential soft skills to ensure accuracy and compliance. These skills are critical for producing precise, regulation-compliant labeling that ensures patient safety and successful product approval.

What are some common challenges freelance medical device labeling specialists face when collaborating with multiple clients?

Freelance medical device labeling specialists often navigate varying regulatory requirements and documentation standards from different clients, which can be challenging. Each client may use different systems for document management and have unique internal review processes, requiring adaptability and strong organizational skills. Additionally, balancing multiple projects with tight deadlines demands effective time management to ensure all labeling materials remain compliant and up to date. Proactive communication and a thorough understanding of regional regulations are crucial for successful collaboration and project delivery.

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

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

What are popular job titles related to Freelance Medical Device Labeling jobs in Wisconsin?

For Freelance Medical Device Labeling jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Freelance Medical Device Labeling jobs in Wisconsin look for?

The top searched job categories for Freelance Medical Device Labeling jobs in Wisconsin are:

What cities in Wisconsin are hiring for Freelance Medical Device Labeling jobs?

Cities in Wisconsin with the most Freelance Medical Device Labeling job openings:

Senior Sanitary Process Engineer

Agile Enterprise Solutions

Sheboygan, WI • On-site

Full-time

Re-posted 26 days ago


Key responsibilities

  • Establish and communicate standards for effective cleaning and sanitization of production processes and surfaces in accordance with GMP standards.

  • Evaluate, develop, and improve cleaning and sanitization programs to ensure GMP compliance and reduce microbiological risk.

  • Collaborate with plant leaders to investigate issues and implement corrective actions related to cleaning and sanitization of equipment and processes.


Job description

Company Description

Founded in 1976, Rockline is a family owned and privately held company
who partners with recognized companies in the healthcare industry and
professional markets. Rockline is one of the world's leading developers,
manufactures, and distributors of coffee filters and wet wipes sold
throughout the world. Rockline is the largest supplier of coffee filters
and private label personal wipes in North America. Rockline's Contract
Manufacturing Services provides development and manufacturing for some
of the largest brands in the market as well as innovative start ups.
Rockline continues to partner with companies in the healthcare
institutional, and professional markets to drive health and safety. Some
of the products manufactured and distributed by Rockline include OTC
antibacterial wipes, disinfectant medical device wipes, household
cleaning and disinfectant wipe products, adult incontinent wipes, and a
variety of personal wipe products for people of all ages.

Job Description

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Chemistry, or other relevant scientific field.

Eight to ten years of direct experience in manufacturing, engineering, quality assurance/engineering, or process cleaning is required. Of those eight to ten years, five must be related to chemical processing and three as a subject matter expert in process cleaning within a GMP industry. Because of the nature of our manufacturing process, your process cleaning experience should come in cosmetics, pharmaceuticals, medical devices, chemical processing, or food production.

Previous experience interpreting and applying regulatory standards and risk analysis techniques

Previous experience leading cross functional teams

Training in and experience performing internal process audits of GMP production areas desired

Ability to develop training materials and effectively train technical and operational staff.

The key functions of this role include:

Establish and communicate common standards for effective cleaning and sanitization of chemical batching processes, fluid delivery processes, and product/material contact surfaces in accordance with applicable GMP standards for all production sites.

Evaluate and develop cleaning and sanitization programs with manufacturing sites to assure compliance with GMP and Rockline standards. Develop common methodologies for the validation of cleaning processes.

Participate with other engineering functions in the development of best practices as it relates to fluid system design, sanitary design standards, and sanitation practices.

Review manufacturing site environmental monitoring programs and propose relevant improvements to reduce microbiological risk.

Work collaboratively with plant leaders regarding investigations, and corrective actions relating to cleaning and sanitization of processing equipment, fluid delivery processes, and product/material contact surfaces.

Develop monitoring and verification programs to continuously improve the overall quality and effectiveness of cleaning and sanitization programs at all manufacturing sites.

Perform or coordinate risk based focused plant audits to identify and correct gaps in hygienic controls, which include sanitation protocols/procedures.

Serve as liaison between Rockline and cleaning/sanitization industry trade group leaders to stay current with respect to technical developments in the areas of process cleaning and sanitization.

Qualifications

Bachelor Degree

Additional Information

All your information will be kept confidential according to EEO guidelines.


Agile Enterprise Solutions logo

About Agile Enterprise Solutions

Sourced by ZipRecruiter

AgileES offers a wide gamut of staffing solutions that are best aligned with requirements of the clients to bring super-colossal benefits for the clients At AgileES, every project whether it is small or big, is looked upon with equal proportion of close attention and commitment. For us, all clients are incomparably invaluable. We listen to our clients and come up with the customized hiring solutions to fulfill all recruitment needs. We are with you every step of the way… the way towards peerless success in business by helping you hire the right people with right business acumen, acuity, intelligence and ingenuity.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Frisco, TX, US

Year founded

2005

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