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ISO 13485

Certifications and Credentials

ISO 13485 is an international standard specifying requirements for a quality management system dedicated to the design, development, production, and servicing of medical devices. Companies pursue certification to demonstrate regulatory compliance and consistent product safety and quality to regulators and customers. Quality assurance and regulatory affairs professionals in the medical device industry need familiarity with its requirements for audits and certification.

ISO 13485 in the job market

Last checked October 28, 2026

Open roles
11

on Career App

Employers
6

hiring for it

Median pay
—

not enough disclosed

Disclose pay
—

of these roles

Open roles requiring ISO 13485 (11)

Varian Medical Systems

Mechanical Test Engineer (w/m/d) Applicators

Varian Medical Systems

Full-time · HNA R

This role involves creating and executing mechanical verification tests for brachytherapy applicators at a medical device company, serving as a central point of contact across engineering, quality, production, and service teams. It suits someone with a technical background and regulatory project experience who can independently manage test protocols and communicate findings across multiple departments.

Listed on Varian Medical Systems’s careers site · Apply there ↗

Sr. Engineer, Design Quality Assurance

Hims and Hers

Minnetonka, MN · $140,000 – $160,000

A senior quality assurance engineer role supporting medical device design, development, and manufacturing at a digital health company. This suits experienced engineers in regulated industries who want to apply design controls, risk management, and validation expertise in a fast-paced environment.

Listed on Hims and Hers’s careers site · Apply there ↗

Senior Regulatory Affairs Specialist

Oura

Remote - United States · $127,500 – $178,000

This role supports regulatory strategy and operations for Oura's software medical devices, handling submissions, documentation, compliance tracking, and cross-functional coordination throughout the product lifecycle. It suits experienced regulatory professionals with a background in medical devices or digital health who thrive managing complex documentation and approval processes in a growing company.

Listed on Oura’s careers site · Apply there ↗

Beckman Coulter

Sr. Microbiology Quality Engineer

Beckman Coulter

Full-time · Hauppauge, NY · $112,000 – $125,000

This role leads complaint and defect tracking for medical device products in a regulated environment, working with cross-functional teams to resolve post-market quality issues and author investigation reports. It suits experienced microbiology professionals with a background in pharmaceutical or medical device quality assurance who want to take on broader leadership and strategic quality responsibilities.

Listed on Beckman Coulter’s careers site · Apply there ↗

Biogen

Head of Quality, Device and Combination Products

Biogen

Cambridge, MA

Lead the quality strategy and global team for medical devices and combination products at a major biotech company, from design through lifecycle management. This role suits an experienced quality professional with deep regulatory knowledge and demonstrated leadership in device manufacturing compliance.

Listed on Biogen’s careers site · Apply there ↗

Manager, Quality Assurance

A-dec

Newberg, OR

This role leads a quality assurance team at a dental equipment manufacturer, overseeing compliance with regulatory standards and driving continuous improvement across the organization. It suits experienced quality professionals with a track record managing teams and implementing quality systems in regulated manufacturing environments.

Listed on A-dec’s careers site · Apply there ↗

Varian Medical Systems

Sr Supplier Quality Engineer (onsite)

Varian Medical Systems

Full-time · PAO H · $139,180 – $191,378

This role oversees supplier quality for medical device products at Varian Medical Systems, ensuring suppliers meet quality standards and driving continuous improvement across manufacturing and field service. It suits experienced engineers with healthcare industry knowledge who can lead cross-functional teams and travel frequently to supplier sites.

Listed on Varian Medical Systems’s careers site · Apply there ↗

Sr. Process & Operations Engineer — Minneapolis, MN

Hims and Hers

Full-time · Minnetonka, MN · $130,000 – $170,000

This role oversees contract manufacturing operations for FDA-regulated medical devices, serving as the technical liaison between internal teams and external manufacturers. It suits experienced process engineers with deep medical device manufacturing expertise who can manage complex regulatory compliance and drive operational excellence across suppliers.

Listed on Hims and Hers’s careers site · Apply there ↗

Quality Assurance Specialist, Sr

A-dec

Newberg, OR

This role manages quality management systems and regulatory compliance for a medical device manufacturer, ensuring adherence to FDA and international standards through internal audits, corrective action programs, and cross-functional coordination. It suits someone with quality assurance experience in regulated industries who is comfortable with compliance documentation and comfortable leading others.

Listed on A-dec’s careers site · Apply there ↗

Sr. Product Development Engineer — Minneapolis, MN

Hims and Hers

Full-time · Minnetonka, MN · $130,000 – $170,000

This role designs and develops FDA-regulated medical devices and their packaging systems, from initial concept through manufacturing transfer. It suits experienced mechanical or biomedical engineers who are comfortable with regulatory compliance, design documentation, and cross-functional collaboration in a fast-moving healthcare setting.

Listed on Hims and Hers’s careers site · Apply there ↗

View all 11 on Jobs

Employers hiring for ISO 13485

6 in total, most open roles first.

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