Sr. Manager Regulatory Affairs

Stryker • Irvine, CA • 2h ago

Join Stryker's Peripheral Vascular division in Irvine, CA , where you'll play a pivotal role in advancing life-enhancing medical technologies. As a Senior Regulatory Affairs Manager - International, you will lead global regulatory strategies that accelerate patient access to innovative solutions and directly shape successful product launches across key international markets. This is an opportunity to make a measurable impact while developing a high-performing team in a fast-moving, mission-driven environment.

What You Will Do

Lead day-to-day global regulatory operations, ensuring activities are accurately evaluated, prioritized, and executed to meet business timelines.

Oversee preparation, review, and submission of regulatory filings supporting market access across EMEA , EU , APAC , and Latin America .

Manage regulatory processes for Patient-Specific Solutions, including compassionate use and special access pathways.

Interpret global regulatory requirements and guide internal teams on submission strategies, labeling compliance, and product claims.

Ensure regulatory submissions, labeling, and marketing materials meet all applicable standards and internal quality expectations.

Represent Regulatory Affairs in internal and external audits with health authorities and Notified Bodies.

Partner with Quality, R&D, Supply Chain, Finance, Sales, and Marketing to drive cross-functional alignment on regulatory deliverables.

Lead and develop a high-performing Regulatory Affairs team, providing coaching, goal setting, issue resolution, and ongoing performance management.

Establish standardized regulatory processes with clear ownership and implement practical process improvements to reduce inefficiencies.

Track and report regulatory metrics, workload distribution, and submission timelines to support operational planning and budget management.

What You Will Need

Required Qualifications

Bachelor's degree required. (Engineering, Science, or related field preferred).

Minimum 10 years of experience in an FDA-regulated industry.

Minimum 3 years of people leadership experience.

Medical device industry experience required.

Preferred Qualifications

Master's degree and/or Regulatory Affairs Certification (RAC).

Experience with international submissions across EMEA, EU, APAC, Latin America, and Canada.

Experience leading geographically dispersed teams.

$167,000-$278,600 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker

Go to Apply

Share this job

Similar Jobs

Customer Service Associate

Walgreens • Fountain Valley, CA • 53min ago

Management & Administrative

Job Description: Models and delivers a distinctive and delightful customer experience. Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. Custome...

53min ago

Go to Apply

Security Officer - Warehouse

GardaWorld • Anaheim, CA • 1h ago

Management & Administrative

Job Description GardaWorld Security Services is Now Hiring a Surveillance Security Officer! Ready to suit up as a Surveillance Security Guard? What matters most about a role like this is your sharp eye, capturing every d...

1h ago

Go to Apply

Account Manager, Commercial Lines

HUB International • Irvine, CA • 1h ago

Management & Administrative

ABOUT HUB: In a rapidly changing world, HUB advises businesses and individuals on how to prepare for the unexpected. As one of the worlds' largest insurance brokers, our focus is dedicated to providing our customers with...

1h ago

Go to Apply

Account Manager, Commercial Lines

HUB International • Newport Beach, CA • 1h ago

Management & Administrative

1h ago

Go to Apply

Sr. Account Manager

The ODP Corporation • Signal Hill, CA • 1h ago

Management & Administrative

Overview The Sr. Account Manager position at ODP Business Solutions has two primary objectives: increasing existing account penetration and servicing existing revenue. Specifically, the position is responsible for travel...

1h ago

Go to Apply

Administrative Support Assistant

Veterans Affairs, Veterans Health Administration • Long Beach, CA • 1h ago

Management & Administrative

Summary The Long Beach VA Medical Center is searching for an Administrative Support Assistant to serve within the Nursing, Spinal Cord Injury (SCI) and Rehab service. Responsibilities Duties include but are not limited t...

1h ago

Go to Apply

10659 - Sr. Manager, Infrastructure Service Management

Hyundai Autoever America • Irvine, CA • 2h ago

Management & Administrative

10659 - Sr. Manager infrastructure Service Management Location: Irvine CA?, 5-days on-site Company Overview: Hyundai Autoever America (HAEA) is the dynamic IT powerhouse behind Hyundai Motor Corporation, a Fortune 500 gl...

2h ago

Go to Apply

Coord, Customer Service

Smurfit Westrock • Corona, CA • 3h ago

Management & Administrative

Description: Receives and processes routine customer orders, inquiries, and/or complaints covering items or products ordered. Maintains an ongoing relationship with selected customers and sales staff. Incumbents utilize...

3h ago

Go to Apply

Territory Account Manager

EquipmentShare • Santa Ana, CA • 3h ago

Management & Administrative

Build the Future with Us - EquipmentShare is Hiring a Territory Account Manager At EquipmentShare, we're not just filling a role - we're assembling the best team on the planet to build something that's never been built b...

3h ago

Go to Apply

Used Truck Sales Manager

Rush Enterprises • Whittier, CA • 5h ago

Management & Administrative

The Used Truck Sales Manager directs and coordinates truck sales activities for the organization. Rush Truck Centers opens the door to the world of opportunity. We are the largest network of commercial vehicle dealership...

5h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.