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Associate 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 ...

Adecco

Labeling and Packaging Associate

Chattanooga, TN · On-site

$26.09/hr

Join the team supported by Adecco in Swiftwater, PA, as a Labeling and Packaging Associate--an ... Comprehensive benefits including medical, dental, vision, and 401(k). * Attractive referral bonuses ...

SurgiCor

Trauma Sales Associate

Ten Mile, TN · On-site

$60 - $90/hr

SurgiCor is looking for a driven, relationship-focused Trauma Sales Associate to join our ... This is a great opportunity for someone early in medical device sales who wants hands-on OR ...

MEDTEK

Be Seen First

Dock Associate & Manual Order picking

Memphis, TN · On-site

$16.50 - $16.75/hr

The Dock Associate & Manual Order Picking role is essential for maintaining efficient warehouse operations within a temperature-controlled medical device environment. This position focuses on precise ...

New

Barrington James

Clinical Specialist

Nashville, TN · On-site

High School Diploma or GED or associate degree with a minimum 4 years in a clinical specialist or related medical role, preferably in a medical device company; OR * Customer relationship and ...

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All JobsAssociate Medical Device Labeling JobsAssociate Medical Device Labeling Jobs in Tennessee

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 Tennessee?

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

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

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

Associate 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 22 days ago

Key responsibilities

  • Prepare and submit regulatory documentation to FDA and other international regulatory agencies.

  • Review, interpret, and communicate regulations and guidance documents to ensure product submission compliance.

  • Support the management of international product registrations, license renewals, and amendments.

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.

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