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Medical Device Testing Jobs in Raleigh, NC (NOW HIRING)

Bioventus

Regulatory Affairs Manager

Durham, NC · On-site

... testing requirements and other documentation to ensure regulatory data requirements are met. . 6. ... Class II medical device experience required, Class III medical device and/or PMA / BLA/NDA ...

Danaher

Software Engineer Internships

Durham, NC

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

Danaher

Software Engineer Internships

Raleigh, NC

Participating on an Agile Scrum team, collaborating across design, development, and testing ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...

RD Partners

Quality Control Analyst

Holly Springs, NC · On-site

$41K - $62K/yr

Your main responsibilities as a Quality Control Analyst: · Performs testing and associated tasks ... medical device companies. R&D Partners is an equal-opportunity employer. If you are interested in ...

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Medical Device Testing information

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How much do medical device testing jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for medical device testing in Raleigh, NC is $35.70, according to ZipRecruiter salary data. Most workers in this role earn between $24.09 and $44.62 per hour, depending on experience, location, and employer.

Does the medical device industry pay well?

Medical device testing professionals typically earn competitive salaries that vary based on experience, location, and certifications. Entry-level roles may start lower, but experienced testers with specialized skills can command higher wages, especially in regulated environments requiring knowledge of quality standards like ISO 13485.

What are the key skills and qualifications needed to thrive in the Medical Device Testing position, and why are they important?

To thrive in Medical Device Testing, you need a strong background in biomedical engineering, quality assurance, and regulatory compliance, often supported by a relevant degree. Hands-on experience with testing equipment, validation protocols, and familiarity with standards such as ISO 13485 and FDA guidelines are typically required. Attention to detail, analytical thinking, and clear documentation skills are essential soft skills for excelling in this field. These abilities ensure that devices meet safety and performance standards, protecting patient health and supporting company compliance.

Will AI replace medical device sales jobs?

AI is unlikely to fully replace medical device sales jobs, as these roles require relationship-building, product knowledge, and negotiation skills that are difficult for AI to replicate. Instead, AI can support sales professionals by providing data analysis, customer insights, and automating routine tasks. Success in this field often depends on interpersonal skills, technical understanding, and certifications, which remain essential despite technological advancements.

What is medical device testing?

Medical device testing involves evaluating medical equipment and devices to ensure they meet safety, performance, and regulatory standards. It includes procedures such as functional testing, durability testing, and compliance verification, often requiring knowledge of industry regulations and testing tools. Professionals in this field may work in controlled environments and need relevant certifications.

What are some typical daily responsibilities for someone working in Medical Device Testing?

Professionals in Medical Device Testing typically spend their days conducting tests on new or existing medical devices to ensure they meet quality, safety, and regulatory standards. This often involves following strict protocols, documenting results accurately, and troubleshooting any performance or compliance issues that arise. Team members frequently collaborate with engineers, regulatory specialists, and manufacturing staff to ensure seamless product development and problem resolution. There may also be tasks related to preparing reports for regulatory submissions or participating in audits. This role offers the opportunity to make a real impact on patient safety while working in a collaborative, fast-paced environment.

What is a Medical Device Testing job?

A Medical Device Testing job involves evaluating medical devices to ensure they meet regulatory standards, safety guidelines, and performance requirements. Professionals in this role conduct tests, analyze data, and document results to verify compliance with industry regulations such as FDA, ISO, and IEC standards. They work with engineers and regulatory teams to identify design flaws, improve product safety, and ensure reliability before market release. This job is crucial for preventing defects that could impact patient health and safety.

Are there any legit product testing jobs?

Medical device testing jobs are legitimate roles that involve evaluating the safety, functionality, and compliance of medical devices. These positions often require knowledge of industry standards, attention to detail, and sometimes certifications or training in quality assurance or regulatory requirements.
What are popular job titles related to Medical Device Testing jobs in Raleigh, NC? For Medical Device Testing jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Medical Device Testing jobs in Raleigh, NC look for? The top searched job categories for Medical Device Testing jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Medical Device Testing jobs? Cities near Raleigh, NC with the most Medical Device Testing job openings:
Medical Device Testing jobs near you

Regulatory Affairs Manager

Bioventus

Durham, NC • On-site

Full-time

Posted 7 days ago

Job description

Are you ready to work for a more active world?
At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and compliance with national and international regulatory requirements (e.g. U.S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory expertise. The position will ensure that company policies, procedures and practices follow appropriate regulatory requirements.
Key Responsibilities:
1. Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.
2. Develop and maintain outstanding relationships with all regulatory and compliance agencies. Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums. Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.
3. Prepares, collects, reviews, and assembles technical documentation required for writing regulatory and clinically-related submissions such as US 510K, PMAs, IDEs, NDAs, INDs, or international dossiers for new and modified products.
4. Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met. .
6. Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products.
7. Monitor proposed and current global regulations and standards; assess impact of changes to such on assigned biologics product lines
8. Maintains awareness of global regulatory legislation and assesses its impact of development and manufacturing initiatives.
9. Evaluates design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.
10. Identifies and facilitates in the remedy of inefficiencies in Quality systems and processes.
11. Contribute to the Regulatory and/or Quality perspective on due diligence activities to identify issues related to the targeted product's development and/or its manufacture.
12. Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
13. All other duties or projects as assigned.
Education and Experience (Knowledge, Skills & Abilities)
  • Bachelor's degree required (study area in Engineering or life sciences preferred, but other degrees may be considered)
  • Knowledge & experience working with biologics
  • Extensive knowledge of FDA and applicable international regulations required.
  • Working knowledge of US Quality Systems Regulations (QSRs) and/or Good Manufacturing Practices (GMPs), along with ISO 13485.
  • Minimum of 5 - 7 years of Regulatory and Quality regulations experience and submission experience required. Class II medical device experience required, Class III medical device and/or PMA / BLA/NDA submissions experience desired.
  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
  • Being detail-oriented while having the ability to handle multiple projects/tasks
  • Experience interacting with US FDA is required

Are you the top talent we are looking for?
Apply now! Hit the "Apply" button to send us your resume and cover letter.
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.

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