ZipRecruiter

Log In

1

Medical Device Labeling Jobs in Massachusetts (NOW HIRING)

previous pagenext page

Showing results 21-40

All JobsMedical Device Labeling JobsMedical Device Labeling Jobs in Massachusetts

Medical Device Labeling information

See Massachusetts salary details

$14

$33

$104

How much do medical device labeling jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for medical device labeling in Massachusetts is $33.34, according to ZipRecruiter salary data. Most workers in this role earn between $18.89 and $42.79 per hour, depending on experience, location, and employer.

What is a medical device labeling?

A Medical Device Labeling job involves creating, reviewing, and managing labeling content for medical devices to ensure compliance with regulatory requirements. This includes instructions for use, packaging labels, and safety information for healthcare professionals and patients. Professionals in this role collaborate with regulatory, quality, and engineering teams to meet industry standards and country-specific regulations. Their work ensures that medical devices are used safely and effectively, reducing risks associated with improper usage.

What are the key skills and qualifications needed to thrive in medical device labeling?

To thrive in Medical Device Labeling, you need a strong understanding of regulatory requirements (such as FDA and EU MDR), attention to detail, and experience with technical writing or documentation, often supported by a degree in life sciences or a related field. Familiarity with labeling management systems, document control tools, and knowledge of ISO standards are key technical qualifications, and certifications like RAC can be advantageous. Strong communication, collaboration, and organizational skills set candidates apart, as these roles often involve coordinating with cross-functional teams such as regulatory, engineering, and quality assurance. These capabilities ensure labeling materials meet strict compliance standards, avoid costly errors or recalls, and support timely product launch and patient safety.

What does a medical device labeling do?

Professionals in Medical Device Labeling are responsible for creating, reviewing, and updating product labels, instructions for use, and packaging materials to ensure compliance with regulatory standards. They often collaborate closely with regulatory affairs, engineering, and quality assurance teams to gather technical product information and incorporate feedback. Daily activities may also include managing document control processes, implementing labeling changes driven by new regulations or product updates, and preparing submissions for global markets. Attention to detail and the ability to manage multiple projects simultaneously are crucial for success in this role.

What are the most commonly searched types of Medical Device Labeling jobs in Massachusetts? The most popular types of Medical Device Labeling jobs in Massachusetts are:
What are popular job titles related to Medical Device Labeling jobs in Massachusetts? For Medical Device Labeling jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Medical Device Labeling jobs in Massachusetts look for? The top searched job categories for Medical Device Labeling jobs in Massachusetts are:
Medical Device Labeling jobs near you
Infographic showing various Medical Device Labeling job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $69,342 per year, or $33.3 per hour.

Senior Regulatory Affairs Specialist

BRIOHEALTH SOLUTIONS INC

Burlington, MA • On-site

$115K - $130K/yr

Full-time

Posted 3 days ago

New

Job description

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.


The Role

BrioHealth Solutions is seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist System. This individual will partner with cross-functional teams to support product development activities, US and EU clinical studies and regulatory planning and submission activities.


What You’ll Do

  • Prepare, review, and maintain FDA submissions supporting the BrioVAD System and the INNOVATE™ Trial, including IDE submissions, supplements, amendments, and annual reports.
  • Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional teams to incorporate regulatory requirements into clinical and product development activities.
  • Provide regulatory guidance on clinical protocols, informed consent materials, investigator communications, labeling, device changes, and other study-related documentation.
  • Assess product, manufacturing, software, labeling, and clinical study changes to determine their regulatory impact and applicable FDA reporting or submission requirements.
  • Support FDA communications and meetings by preparing materials, coordinating cross-functional input, and tracking regulatory questions and commitments.
  • Review technical, clinical, and quality documentation for accuracy, consistency, and submission readiness.
  • Monitor changes to U.S. regulations, FDA guidance, and relevant industry standards; evaluate their impact and communicate applicable requirements to internal stakeholders.
  • Maintain accurate regulatory records, submission files, agency correspondence, approvals, and commitments in accordance with internal procedures.
  • Manage multiple regulatory deliverables and timelines while proactively identifying and escalating risks or potential delays.
  • Support EU MDR regulatory strategy and CE marking activities for the BrioVAD® LVAS, including planning for conformity assessment, Notified Body interactions, and maintenance of EU regulatory deliverables.
  • Contribute to preparation, review, and lifecycle maintenance of EU technical documentation, including General Safety and Performance Requirements (GSPR) evidence, clinical evaluation documentation, post-market surveillance inputs, and related submission-ready records.
  • Support EU clinical and post-market obligations, including clinical investigation documentation, PMCF planning, vigilance inputs, field safety communications, periodic reporting, and responses to regulatory or Notified Body questions, as applicable.
  • Evaluate design, manufacturing, software, labeling, supplier, and clinical study changes for EU regulatory impact, including potential effects on CE marking, technical documentation, GSPR compliance, UDI/EUDAMED data, and Notified Body notification requirements.
  • Coordinate with Authorized Representative, importer/distributor, Notified Body, and internal stakeholders to ensure EU regulatory commitments, timelines, and evidence needs are identified, tracked, and fulfilled.


What You Bring

  • Bachelor’s degree in life sciences, engineering, or a related technical discipline required; advanced degree preferred.
  • At least five years of medical device regulatory affairs experience with a bachelor’s degree, or at least three years with an advanced degree.
  • Working knowledge of applicable U.S. medical device regulations, including 21 CFR Parts 11, 50, 54, 56, 812, and 820.
  • Experience preparing or supporting FDA medical device submissions, such as IDE or PMA submissions, supplements, amendments, annual reports, and regulatory responses.
  • Working knowledge of EU MDR 2017/745 requirements, including CE marking, technical documentation, GSPR, clinical evaluation/PMCF, PMS, vigilance, UDI, and EUDAMED expectations.
  • Experience supporting Notified Body submissions or interactions, EU technical documentation, and/or CE mark maintenance for Class III, implantable, active, cardiovascular, or life-sustaining medical devices preferred.
  • Familiarity with ISO 13485, ISO 14971, applicable harmonized standards, MDCG guidance, and EU medical device regulatory intelligence processes preferred.
  • Experience supporting medical device clinical studies and collaborating with clinical, technical, and quality teams.
  • Class III medical device experience strongly preferred; experience with active implantable, cardiovascular, or life-sustaining devices is highly desirable.
  • Ability to assess regulatory requirements and implications across product, software, manufacturing, labeling, and clinical study changes.
  • Strong technical writing, communication, analytical, and organizational skills.
  • Ability to manage competing priorities, exercise sound judgment, and work independently in a fast-paced environment.