Remote Senior Regulatory Affairs Specialist Jobs
Remote Senior Regulatory Affairs Specialist jobs are available nationwide at employers like Oscar Health, Otsuka, and Mitsubishi and other distributed teams, at every experience level. Find a role that fits below and apply directly.
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Showing 5 of 39+ Remote Senior 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 Senior Regulatory Affairs Specialist Jobs
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Find JobsRemote Senior 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 senior regulatory affairs specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field required
- Five or more years of regulatory affairs experience in pharmaceuticals, medical devices, or biotechnology
- Direct experience preparing and submitting FDA regulatory filings such as 510(k)s, NDAs, or BLAs
- Proficiency with eCTD publishing and regulatory information management systems such as Veeva Vault
- Regulatory Affairs Certification (RAC) from RAPS preferred or required for senior-level roles
- Strong working knowledge of FDA regulations, ICH guidelines, and applicable CFR sections
Tips for Your Remote Senior Regulatory Affairs Specialist Job Search
Tailor your resume to submission types
Hiring managers scan for specific submission experience, whether that's 510(k)s, PMAs, NDAs, or BLAs. List each type you've led or contributed to by name so your resume clears keyword filters and signals hands-on regulatory depth immediately.
Highlight your regulatory database proficiency
Many postings require experience with Veeva Vault, RIMS, or eCTD publishing tools. Name each system you've used and describe the context, such as managing submissions or maintaining registration records, so recruiters don't have to guess.
Apply early to roles that fit
Migrate Mate lists senior regulatory affairs specialist openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Match your cover letter to the product stage
Regulatory work at a pre-market startup differs sharply from post-market compliance at an established manufacturer. Reference whether you prefer early-stage submissions or lifecycle management, and connect that preference directly to where the company's product sits.
Prepare case studies around agency interactions
Interview panels often ask how you handled an FDA deficiency letter, responded to a clinical hold, or negotiated label language. Walk through one real example with a clear problem, your specific action, and the outcome, without relying on vague teamwork language.
Negotiate based on scope, not just title
Senior regulatory affairs specialist roles vary widely in authority over strategy versus execution. Before accepting an offer, confirm whether you own submissions end-to-end or support them, since that scope difference affects both your daily work and your next career move.
Remote Senior Regulatory Affairs Specialist Jobs: Frequently Asked Questions
How do I get a remote senior regulatory affairs specialist job?
Target companies that already run distributed teams, since they hire remotely by default and know how to onboard someone they never meet in person. Remote senior regulatory affairs specialist employers screen hard for self-direction and clear written communication on top of the core skills, so show evidence you can own work without someone over your shoulder. Apply to the openings above that match your experience.
Which companies hire remote senior regulatory affairs specialists?
Remote senior regulatory affairs specialist 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. Remote-first firms and large companies running distributed teams post the most remote senior regulatory affairs specialist roles.
Can you get a remote senior regulatory affairs specialist job with no experience?
Yes, but it is harder than an on-site role, because remote work expects you to operate independently from the start. Entry-level remote senior regulatory affairs specialist openings do exist, especially at remote-first companies, and a portfolio of real work helps more than a long resume. Applying broadly to the roles that fit improves your odds.
Do you need a degree for remote senior regulatory affairs specialist jobs?
Not always. Many employers hire remote senior regulatory affairs specialists on demonstrated skills and prior work rather than a specific degree, though some larger companies still prefer one. Showing relevant results matters more than a credential for most remote senior regulatory affairs specialist roles.
Which industries hire the most remote senior regulatory affairs specialists?
Remote senior regulatory affairs specialist roles concentrate in Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of June 2026. These sectors run distributed teams and hire senior regulatory affairs specialists remotely most consistently.
See All 39 Remote Senior Regulatory Affairs Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
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