1,039 State Licensure jobs in the United States

Join Stryker's Neurovascular Division in Fremont, CA or Salt Lake City, Utah as a Regulatory Affairs Specialist. At Stryker, we're driven by a mission to "Make Stroke History." Our Neurovascular division is dedicated to advancing minimally invasive stroke therapies through our Complete Stroke Care solutions. We offer innovative products and services for both ischemic and hemorrhagic stroke, including stent retrievers, detachable coils, stents, balloons, guidewires, and microcatheters. As part of our team, you'll play a critical role in supporting regulatory strategies that help bring life-saving technologies to patients and empower physicians to deliver better outcomes. Stroke remains a leading cause of death-accounting for 1 in 20 deaths according to the CDC-and your work will directly contribute to changing that statistic. Watch this video to see how Stryker is making a difference: .

Workplace Flexibility: Candidate must reside within a commutable

distance to Fremont, CA but is expected to be onsite at the facility multiple times/week.

What you will do

• Support the Neurovascular product portfolio by assessing design, manufacturing, and labeling changes to ensure regulatory compliance throughout the product lifecycle.

• Advise cross-functional teams on regulatory pathways and requirements for changes to marketed devices in the US, EU, and Canada.

• Develop and update regulatory strategies in response to evolving regulations and product modifications.

• Evaluate regulatory environments and anticipate potential obstacles, proposing proactive solutions.

• Assess preclinical, clinical, and manufacturing changes to determine appropriate regulatory filing strategies or alternatives.

• Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable guidelines and monitor review progress.

• Ensure alignment of clinical and nonclinical data with regulatory requirements to support product claims.

• Communicate effectively with regulatory authorities during submission development and review processes.

What you need:

Required

• A bachelor's degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.

Preferred

• Familiarity with FDA-regulated or other highly compliant industries, with a solid understanding of regulatory standards and practices.

• Exposure to Medical Device Regulatory Affairs or Engineering through coursework, internships, or project-based experience.

• RAC certification or Advanced Degree (Masters in Regulatory Affairs).

• Possesses a solid understanding of the product development process and design control principles, with prior experience working with U.S. Class II and Class III medical devices.

• Demonstrates strong analytical and writing skills, effective organizational abilities, and advanced proficiency in Microsoft Office Suite, particularly Excel.

69,100.00 to 139,600.00 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.

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you'll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.

Why You Should Apply

• Join a company that thrives on innovation and real-world patient impact
• Collaborate with cross-functional experts in a fast-paced, clinical product environment
• Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
• Enjoy a culture that blends urgency, teamwork, and a passion for clinical results

What You'll Be Doing

• Drafting and submitting 510(k), IDE, and PMA regulatory submissions
• Partnering with Product Development teams to align on regulatory strategy
• Reviewing clinical data and collaborating with internal teams to support submissions
• Maintaining PMA records, preparing supplements and annual reports
• Training team members and contributing to SOP development and regulatory compliance

About You

• Be able to do the job as described
• Bachelor's in health/science-related field; Engineering degree is a plus
• 2-5 years' experience in Regulatory Affairs in the medical device industry
• Knowledge of orthopedic medical devices is highly preferred
• Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
• Strong documentation, review, and cross-functional communication skills

The Senior Global Labeling Coordinator is responsible for providing advanced specialized operational support to the RA GL Manager, GL-TAL and Head GL related to the creation and maintenance of core labeling packages for development programs and marketed products, including the coordination of global labeling activities according to regulatory requirements and company standards.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

Working at Bec LS means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Beckman Life Sciences you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs Intern will gain hands-on experience in regulatory strategy, documentation, and compliance within the life sciences industry. You'll work alongside experienced professionals to support regulatory submissions and ensure alignment with global standards.

This position reports to the Senior Manager, Regulatory Affairs and is part of the Flow Cytometry business located in Miami and will be an on-site role.

• Assist in the preparation, review, and submission of regulatory documents to health authorities
• Support regulatory tracking systems and maintain documentation databases
• Conduct research on regulatory requirements and industry guidelines
• Collaborate with cross-functional teams including R&D, Quality, and Clinical Affairs
• Help ensure compliance with applicable regulations, standards, and company policies

• Currently pursuing a bachelor's or master's degree in Regulatory Affairs, Life Sciences, Pharmacy, Public Health, or a related discipline
• Strong attention to detail and organizational skills
• Excellent written and verbal communication abilities
• Familiarity with regulatory terminology and documentation practices
• Ability to work independently and in a team environment

It would be a plus if you also possess previous experience in:

• Prior internship or coursework in regulatory affairs or quality assurance
• Understanding of FDA, EMA, or ICH guidelines
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

The hourly range for this role is $30.00. This is the rate that we in good faith believe is the rate of compensation for this role at the time of this posting.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or