Remote Regulatory Affairs Specialist Jobs
Remote regulatory affairs specialist jobs are open across the U.S. in pharmaceutical, biotech, medical device, and consumer products companies, from entry-level regulatory coordinators to senior directors managing global submissions on distributed teams. Employers hiring remotely right now include Oscar Health, Otsuka, and Mitsubishi. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 39+ Remote Regulatory Affairs Specialist 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 Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsRemote Regulatory Affairs Specialist 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 specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Experience preparing and submitting regulatory filings such as 510(k), PMA, NDA, or BLA
- Knowledge of FDA regulations including 21 CFR parts relevant to the product type
- Proficiency with regulatory information management systems such as Veeva Vault or RIMS
- Regulatory Affairs Certification (RAC) from RAPS preferred for senior roles
- Strong technical writing skills for preparing regulatory summaries, briefing documents, and SOPs
Tips for Your Remote Regulatory Affairs Specialist Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs specialist openings from across the U.S. in one place, so you can find roles that match your background and apply directly. Remote postings attract high applicant volume fast, so applying within the first few days of a listing matters.
Show async communication skills upfront
Remote regulatory affairs employers prioritize candidates who can communicate precisely in writing without real-time back-and-forth. In your cover letter and resume, highlight experience writing submission summaries, SOPs, or regulatory correspondence that others acted on without clarifying calls.
Demonstrate fluency with remote regulatory tools
Call out your hands-on experience with document management and submission platforms like Veeva Vault, MasterControl, or eCTD publishing tools. Remote teams cannot afford onboarding time for software basics, so naming specific platforms signals you can contribute from day one.
Target companies with established distributed teams
Remote regulatory affairs roles are most stable at companies that already run distributed regulatory or clinical teams, not those testing remote work for the first time. Look for job descriptions that reference cross-functional remote collaboration, multiple time zones, or global regulatory strategy.
Prep your remote interview around self-management
Remote regulatory affairs interviews consistently probe how you track submission deadlines, handle ambiguous agency feedback, and stay aligned with cross-functional partners without shared office space. Prepare specific examples of managing complex timelines or resolving regulatory questions independently.
Remote Regulatory Affairs Specialist Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs specialist job?
Remote regulatory affairs specialist roles go to candidates who can demonstrate self-direction, precise written communication, and fluency with document management systems like Veeva Vault or MasterControl. Remote employers screen heavily for async collaboration skills, comfort with cross-functional digital workflows, and the ability to manage submissions and timelines without in-person oversight. Certifications like RAC from RAPS give your application a concrete edge over generalist candidates.
Which companies hire remote regulatory affairs specialists?
Companies hiring remote regulatory affairs specialists right now include Oscar Health, Otsuka, and Mitsubishi, based on current remote listings on Migrate Mate as of June 2026. Remote regulatory affairs roles concentrate at pharmaceutical companies, medical device manufacturers, biotech firms, and contract research organizations that operate distributed regulatory teams across multiple markets.
Can you get a remote regulatory affairs specialist job with no experience?
Yes, but remote entry-level regulatory affairs roles are harder to land because employers expect you to work independently from day one with minimal supervision. Your strongest entry points are contract research organizations and startups that hire junior regulatory coordinators remotely. In place of experience, show familiarity with FDA submission processes, regulatory databases, and document control tools, and highlight any coursework, internships, or independent projects involving compliance or technical writing.
Do you need a degree for remote regulatory affairs specialist jobs?
Usually, but the field is more credential-flexible than many assume. Most remote employers prefer a bachelor's in a life sciences, chemistry, or engineering discipline, but candidates who hold RAC certification and can show hands-on submission experience, strong technical writing, and working knowledge of FDA or international regulatory frameworks are competitive even without a traditional degree path.
Which industries hire the most remote regulatory affairs specialists?
The sectors hiring the most remote regulatory affairs specialists are Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of June 2026. These industries hire regulatory affairs specialists remotely because their submission, compliance, and labeling work is documentation-driven and integrates naturally into distributed team structures across time zones.
See All 39 Remote Regulatory Affairs Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
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