ZipRecruiter

Log In

1

Freelance Medical Device Labeling Jobs in Tennessee

Revance

Regulatory Device Specialist

Johnson City, TN · On-site

$65K - $73K/yr

... for medical devices. * Reports to: Regulatory Affairs Manager * Location: Remote with occasional ... Review labeling, Instructions for Use, and promotional materials for country-specific content ...

Revance

Regulatory Device Specialist

Johnson City, TN · Remote

$65K - $73K/yr

... for medical devices. * Reports to: Regulatory Affairs Manager * Location: Remote with occasional ... Review labeling, Instructions for Use, and promotional materials for country-specific content ...

PrideStaff

Quality Assurance Inspector

Memphis, TN · On-site

$19 - $21.50/hr

The Quality Assurance Inspector will ensure every medical device produced is safe and compliant ensuring the final product matches the prototype and box label. The ideal Quality Assurance Inspector ...

Medtronic

Sr. Manufacturing Engineer

Memphis, TN · On-site

$88K - $120K/yr

Experience in medical device packaging process development * DFM/ Lean/ Six Sigma belt ... Experience with Transform, Loftware, and TK Central labeling platforms * Experience supporting ...

SK Food Group

PIT Operator

Mcdonald, TN · On-site

$14.25 - $16.25/hr

Positions forks, lifting platform, or other lifting device under, over, or around loaded pallets ... Weighs materials or products and records weight on tags, labels, or production schedules. * Loads ...

SK FOOD GROUP

PIT Operator

Mcdonald, TN · On-site

Positions forks, lifting platform, or other lifting device under, over, or around loaded pallets ... Weighs materials or products and records weight on tags, labels, or production schedules. * Loads ...

next page

Showing results 1-20

All JobsMedical Device Labeling JobsFreelance Medical Device Labeling JobsFreelance Medical Device Labeling Jobs in Tennessee

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 Tennessee?

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

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

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

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

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

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

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

Freelance Medical Device Labeling jobs near you

Regulatory Device Specialist

Revance

Johnson City, TN • On-site

$65K - $73K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 8 days ago

Job description

Position Summary:
The Regulatory Device Specialist prepares and submits high quality routine regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. They will also support the preparation, review and archival of electronic and paper regulatory submissions ensuring compliance with FDA and other Health Authorities, company policies and procedures under the guidance of regulatory management.
This position serves as a subject matter expert on various domestic and foreign regulations for medical devices.
  • Reports to: Regulatory Affairs Manager
  • Location: Remote with occasional travel
  • Salary: *$65,000-$73,000 annually + annual performance bonus

*The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location.
Essential Roles and Responsibilities:
  • Prepare pre-market submission reports / technical files per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU, APAC, Middle East).
  • Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
  • Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission).
  • Assist in the update, enhancement, and creation of internal policies and procedures.
  • Supports regulatory compliance to QSR, ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.
  • Compile, submit, and manage international product registrations, license renewals, and registration amendments, including FDA 510(k)s, Health Canada Medical Device Licences, EU MDR Technical Documentation, UKCA, TGA (Australia), PMDA (Japan), ANVISA (Brazil), NMPA (China), MFDS (South Korea), COFEPRIS (Mexico), SFDA (Saudi Arabia), and MOHAP (UAE).
  • Prepare and manage export and country-specific documentation, including Certificates to Foreign Government (CFG), Certificates of Free Sale, Declarations of Conformity, ISO 13485/MDSAP certificates, and Letters of Authorization, and coordinate notarization, apostille, legalization, and consularization as required.
  • Assess new market opportunities by determining device classification, registration pathway, submission content, expected timelines, and in-country representation requirements; provide registration strategy input to new product launch and market entry plans.
  • Review labeling, Instructions for Use, and promotional materials for country-specific content, symbols, translation, and UDI requirements, and support product data submissions to GUDID, EUDAMED, and other national registries.
  • Support Notified Body, MDSAP, and international regulatory inspections and audits, including preparation of requested documentation and follow-up on findings and nonconformities.
  • Monitor and interpret evolving global regulations and guidance (e.g., EU MDR, UKCA transition, IMDRF harmonization initiatives), assess business impact, and communicate required actions to cross-functional stakeholders.
  • Perform other duties as assigned.

Preferred Experience:
  • Minimum of 3 years Medical Device Regulatory Experience required; aesthetics experience preferred
  • Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and EU MDR requirements
  • Demonstrated experience obtaining and maintaining medical device registrations in at least three major markets outside the United States (e.g., EU, UK, Canada, Australia, Japan, China, Brazil, LATAM, Middle East, or APAC).
  • Hands-on experience authoring or compiling regulatory dossiers in multiple formats, including FDA 510(k), EU MDR 2017/745 Technical Documentation, IMDRF/STED Table of Contents, and ASEAN CSDT submissions.
  • Working knowledge of MDSAP, UKCA, and Notified Body review processes, and of country-specific labeling, translation, and UDI/registry requirements.
  • Ability to manage multiple concurrent international submissions across time zones

Preferred Education:
  • Bachelor's degree from a four year college or university.

Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
What Revance invests in you:
  • Competitive Compensation including base salary and annual performance bonus.
  • Flexible PTO, holidays, and parental leave.
  • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Apply