1

Medical Device Regulatory Analyst Jobs (NOW HIRING)

Provide regulatory analysis of product portfolio and review with other functional resources, such ... Or minimum 0 Years of medical device regulatory experience with an advanced degree Nice to Have

Provide regulatory analysis of product portfolio and review with other functional resources, such ... Or minimum 0 Years of medical device regulatory experience with an advanced degree Nice to Have

Provide regulatory analysis of product portfolio and review with other functional resources, such ... Or minimum 0 Years of medical device regulatory experience with an advanced degree Nice to Have

PA · On-site

$89K - $141K/yr

Regulatory and compliance mindset Preferred: * Experience with software as a medical device (SaMD) or digital health platforms. * Familiarity with FDA MDR (21 CFR Part 803) and post-market ...

Medical Device Integration Analyst- NY, NY Salary: $75,000- $85,000/yr Other Forms of Compensation ... Our programs support 100% regulatory compliance and drives 98% equipment uptime--so clinicians can ...

Working knowledge of applicable international medical device regulations, guidance documents, standards, and quality system requirements. * Excellent regulatory, technical, analytical, problem ...

Showing results 41-60

Medical Device Regulatory Analyst information

See salary details

$39.5K

$85.8K

$130K

How much do medical device regulatory analyst jobs pay per year?

As of Sep 9, 2026, the average yearly pay for medical device regulatory analyst in the United States is $85,812.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,500.00 and $100,000.00 per year, depending on experience, location, and employer.

What are popular job titles related to Medical Device Regulatory Analyst jobs?

For Medical Device Regulatory Analyst jobs, the most frequently searched job titles are:

Infographic showing various Medical Device Regulatory Analyst job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $85,812 per year, or $41.3 per hour.

Regulatory Affairs Specialist (Bedford, MA)

Bedford, MA

CEDENT
IT Services • 11 - 50 employees

Full-time

Re-posted 22 days ago


Job description

Responsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA. Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.

Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the Notified Body. Support submission and maintenance of product registrations in markets worldwide. Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.

Assist in external audits by supporting responses to auditor questions and requests. Keep abreast of new or changed regulations and standards and perform gap analyses. Perform additional duties as assigned.

Qualifications: (REQUIRED) Bachelor's degree, preferably in the life sciences; advanced degree a plus. (REQUIRED) At least 3 years of experience in medical device field, including hands-on experience with submissions. Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA

Experience with software-driven and electro-mechanical medical devices a plus. Strong knowledge of US and international requirements for regulatory submissions and maintenance of medical devices. Team player with ability to work independently in hybrid/in-person setting (Bedford, MA).

Excellent and effective written and verbal communication skills. Excellent interpersonal skills, good judgment and analytical skills. Effective time management and organizational skills.

Consistent, quality work and commitment to follow-through.


Cedent logo

About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008