Remote Senior Director Regulatory Affairs Jobs
Remote Senior Director Regulatory Affairs 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 Director Regulatory Affairs 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 Director Regulatory Affairs Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsRemote Senior Director Regulatory Affairs 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 director regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- 10 or more years of regulatory affairs experience in pharmaceutical, biotech, or medical device sectors
- Direct experience leading FDA submissions such as NDAs, BLAs, 510(k)s, or PMAs
- Demonstrated ability to manage cross-functional teams and lead regulatory strategy across product lifecycles
- Familiarity with ICH guidelines, 21 CFR regulations, and international regulatory frameworks
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
Tips for Your Remote Senior Director Regulatory Affairs Job Search
Tailor your resume to submission types
Hiring managers want to see which submission types you've owned, whether NDAs, BLAs, 510(k)s, or PMAs. List the specific pathway, the product type, and whether you led the strategy or the execution. Generic regulatory experience won't differentiate you at the director level.
Apply early to roles that fit
Migrate Mate lists senior director regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Quantify your regulatory approval outcomes
Approvals, timelines compressed, and submissions completed are the metrics that resonate with hiring committees. If you've reduced a submission cycle from 18 months to 12, say so. Directors who can translate regulatory work into business outcomes stand out against candidates who list only responsibilities.
Target openings by agency interaction level
Some roles are primarily internal, while others require frequent FDA meetings, Type B interactions, or agency correspondence. Identify which type fits your background and filter accordingly when you search, so your cover letter speaks directly to the scope the employer actually needs.
Prepare a 90-day regulatory plan for interviews
Senior director interviews often include a strategic scenario: how would you assess the regulatory posture here and what would you prioritize? Preparing a brief, structured framework, covering pipeline review, SOP gaps, and agency relationship audit, gives you a concrete answer ready to go.
Negotiate scope before you negotiate title
At this level, reporting structure and budget authority matter as much as compensation. Before your final interview round, clarify whether the role owns the regulatory strategy or executes someone else's, and whether you'd have direct FDA communication authority. Misalignment on scope is a common reason senior hires leave within the first year.
Remote Senior Director Regulatory Affairs Jobs: Frequently Asked Questions
How do I get a remote senior director regulatory affairs 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 director regulatory affairs 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 director regulatory affairss?
Remote senior director regulatory affairs 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 director regulatory affairs roles.
Can you get a remote senior director regulatory affairs 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 director regulatory affairs 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 director regulatory affairs jobs?
Not always. Many employers hire remote senior director regulatory affairss 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 director regulatory affairs roles.
Which industries hire the most remote senior director regulatory affairss?
Remote senior director regulatory affairs 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 director regulatory affairss remotely most consistently.
See All 39 Remote Senior Director Regulatory Affairs Jobs
Find roles that match your experience and apply in just a few clicks.
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