Remote Regulatory Affairs Associate Jobs
Remote regulatory affairs associate jobs are open across the U.S. at remote-first firms and distributed teams in pharma, biotech, medical devices, and consumer health. Employers hiring remotely right now include Oscar Health, Otsuka, and Mitsubishi. Find a role that fits below and apply directly.
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Showing 5 of 39+ Remote Regulatory Affairs Associate jobs
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
Stryker is currently seeking a Staff Regulatory Affairs Specialist to join our Ortho Tech – Mako and Enabling Technologies division to be based in Weston, Florida or remotely anywhere within the United States.
As the Staff Regulatory Affairs Specialist, you will join a regulatory affairs team supporting a portfolio of advanced orthopedic technologies across U.S. and global markets. You will work cross-functionally to ensure products remain compliant and available in dynamic regulatory environments. This role focuses on sustaining regulatory compliance, managing post-market activities, and supporting submission strategies for modified and existing products.
What you will do
- Develop and execute regulatory strategies for post-market products to maintain market access across global regions.
- Evaluate regulatory requirements and identify submission pathways for product changes, ensuring alignment with applicable regulations.
- Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals and updates.
- Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
- Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
- Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
- Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
- Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.
What you need
Required
- Bachelor’s degree in engineering, science, or related field
- Minimum 4 years of experience in an FDA-regulated industry
- Minimum 2 years of experience in regulatory affairs
- Experience supporting regulatory submissions or compliance activities
- Knowledge of U.S. and international medical device regulations
Preferred
- Experience with Class II or Class III medical devices
- Experience authoring 510(k) submissions or equivalent regulatory filings
- Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
- Experience interacting with regulatory agencies or supporting regulatory meetings
Posted Date: 06/26/2026
This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
Stryker is currently seeking a Staff Regulatory Affairs Specialist to join our Ortho Tech – Mako and Enabling Technologies division to be based in Weston, Florida or remotely anywhere within the United States.
As the Staff Regulatory Affairs Specialist, you will join a regulatory affairs team supporting a portfolio of advanced orthopedic technologies across U.S. and global markets. You will work cross-functionally to ensure products remain compliant and available in dynamic regulatory environments. This role focuses on sustaining regulatory compliance, managing post-market activities, and supporting submission strategies for modified and existing products.
What you will do
- Develop and execute regulatory strategies for post-market products to maintain market access across global regions.
- Evaluate regulatory requirements and identify submission pathways for product changes, ensuring alignment with applicable regulations.
- Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals and updates.
- Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
- Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
- Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
- Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
- Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.
What you need
Required
- Bachelor’s degree in engineering, science, or related field
- Minimum 4 years of experience in an FDA-regulated industry
- Minimum 2 years of experience in regulatory affairs
- Experience supporting regulatory submissions or compliance activities
- Knowledge of U.S. and international medical device regulations
Preferred
- Experience with Class II or Class III medical devices
- Experience authoring 510(k) submissions or equivalent regulatory filings
- Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
- Experience interacting with regulatory agencies or supporting regulatory meetings
Posted Date: 06/26/2026
This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
See All 39 Remote Regulatory Affairs Associate Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsRemote Regulatory Affairs Associate Job Market
Who's Hiring
- Oscar Health3
- Otsuka2
- Mitsubishi2
- BeOne Medicines2
- Caris Life Sciences2
Top Industries Hiring
- Biotechnology & Pharmaceuticals15
- Insurance4
- Science & Research4
- Medical Devices3
- Automotive2
What Employers Look For
The qualifications that appear most often in remote regulatory affairs associate jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related scientific field
- Hands-on experience preparing or supporting FDA regulatory submissions such as 510(k), NDA, or BLA
- Working knowledge of FDA regulations including 21 CFR Parts 11, 820, and 210/211
- Proficiency with regulatory information management systems and electronic document control software
- Strong technical writing skills demonstrated through SOPs, labeling documents, or regulatory summaries
- Regulatory Affairs Certification (RAC) from RAPS or active candidacy preferred by many employers
Tips for Your Remote Regulatory Affairs Associate Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs associate openings from across the U.S. in one place, so you can find roles that match your background and apply directly without sorting through mixed results from general job sites.
Prove async communication skills upfront
Remote regulatory teams run almost entirely through written channels. Include a writing sample, such as a drafted SOP section, a regulatory summary, or a clear email thread resolving a submission question, in your application materials to show you can communicate precisely without a meeting.
Build fluency with remote submission tools
Remote employers screen for hands-on experience with eCTD publishing software, electronic document management systems, and FDA gateway portals. If you haven't used these in a paid role, get familiar through coursework, practice environments, or regulatory association resources before applying.
Prepare for asynchronous interview stages
Many distributed regulatory teams use recorded video screens or written case exercises before any live interview. Practice explaining a mock submission gap or a labeling discrepancy in writing or on camera so your answers are clear, structured, and self-contained without back-and-forth follow-up.
Demonstrate regulatory self-direction on your resume
Remote hiring managers want evidence you can manage timelines and flag compliance issues without daily oversight. Quantify projects you owned end-to-end, such as submissions you tracked from IND to approval or SOPs you drafted and drove through review, to show you operate independently.
Remote Regulatory Affairs Associate Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs associate job?
Target companies with fully distributed regulatory teams, such as remote-first biotechs, contract research organizations, and digital health firms that run their submissions workflows entirely online. Remote employers screen heavily for self-direction and written communication, since you'll coordinate with cross-functional teams asynchronously. Demonstrating fluency with regulatory document management systems, eCTD formatting tools, and electronic submission platforms gives you a clear edge over candidates without that hands-on experience.
Which companies hire remote regulatory affairs associates?
Remote regulatory affairs associate roles are posted by Oscar Health, Otsuka, and Mitsubishi and others right now, based on current remote listings on Migrate Mate as of June 2026. Hiring is concentrated among remote-first biotech and medical device firms, contract research organizations, and large pharma companies with distributed regulatory operations teams.
Can you get a remote regulatory affairs associate job with no experience?
Yes, but remote entry-level regulatory affairs associate roles are harder to land because employers expect you to work independently from day one without in-person mentorship. Remote-first biotechs and CROs occasionally hire entry-level candidates who can show completed regulatory coursework, a RAC exam in progress, or volunteer work on submission projects. A writing sample demonstrating clear technical communication goes a long way when direct experience is limited.
Do you need a degree for remote regulatory affairs associate jobs?
Usually, but the field matters more than the prestige of the institution. Most remote employers expect a bachelor's degree in a life sciences, pharmacy, or engineering discipline. What they weigh alongside the degree is hands-on familiarity with FDA submission formats, 21 CFR Part 11 compliance, and document control systems, so candidates who can show real regulatory project work alongside their credentials stand out.
Which industries hire the most remote regulatory affairs associates?
The sectors hiring the most remote regulatory affairs associates are Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of June 2026. These industries rely on distributed regulatory teams to manage submissions, compliance reviews, and labeling workflows across multiple time zones without requiring staff to be on-site.
See All 39 Remote Regulatory Affairs Associate Jobs
Find roles that match your experience and apply in just a few clicks.
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