Stryker Corporation

Staff Regulatory Affairs Specialist (Pharmaceutical Products)

Stryker Corporation • $105K — $175K *
Cary, IL 60013In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related field.
  • 4+ years of experience in an FDA-regulated or highly regulated industry.
  • 2+ years of Regulatory Affairs experience in the medical device or pharmaceutical industry.
  • Experience assessing regulatory impact of product and manufacturing changes.
  • Proven history of preparing or supporting drug regulatory submissions.

Responsibilities

  • Prepare and author annual reports and regulatory submissions for approved pharmaceutical products.
  • Assess changes to products and processes for appropriate regulatory requirements.
  • Develop and submit amendments and supplements in line with regulations.
  • Review technical documentation for accuracy and completeness before submission.
  • Research regulatory requirements and standards to aid product development.
  • Communicate with regulatory agencies on submission strategies and inquiries.
  • Collaborate with cross-functional teams to achieve regulatory objectives.

Benefits

  • Work flexibility with a hybrid work model.
  • Support for professional development in regulatory affairs.
  • Opportunity to collaborate with diverse engineering, quality, and clinical teams.
Full Job Description
Work Flexibility: Hybrid

Stryker is seeking a Staff Regulatory Affairs Specialist, (Pharmaceutical Products) to join our Medical Division. This is a hybrid role based in Cary, IL.

As the Staff Regulatory Affairs Specialist, you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities.

What you will do

  • Prepare and author annual reports and other regulatory submissions required for approved pharmaceutical products.
  • Assess product, process, and manufacturing changes to determine appropriate regulatory reporting requirements and submission pathways.
  • Develop and submit amendments, supplements, and other regulatory filings in accordance with applicable regulations and guidance.
  • Review technical documentation and regulatory content to ensure accuracy, completeness, and submission readiness.
  • Research regulatory requirements, standards, guidance documents, and approval pathways to support product development and lifecycle management.
  • Communicate with regulatory agencies regarding submission strategies, regulatory pathways, submission status, and responses to agency inquiries.
  • Partner with engineering, quality, clinical, manufacturing, and marketing teams to support regulatory objectives during product development and sustaining activities.
  • Develop and communicate regulatory guidance, requirements, and compliance considerations to support business and project goals.


What you need

Required
  • Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related discipline.
  • Minimum 4 years of experience in an FDA-regulated or other highly regulated industry.
  • Minimum 2 years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry.
  • Experience reviewing regulatory requirements and assessing regulatory impact of product, process, or manufacturing changes.
  • Experience preparing, authoring, or supporting drug regulatory submissions, including submissions for product approvals, post-approval changes, or lifecycle management activities.


Preferred
  • Regulatory Affairs Certification (RAC) or Master's degree in Regulatory Affairs or a related field.
  • Experience preparing or supporting international regulatory submissions and registrations.
  • Experience interacting directly with regulatory agencies.
  • Regulatory Affairs Certification (RAC) or Master's degree in Regulatory Affairs or a related field.


  • US10: $105,300 - $175,500 USD Annual


Travel Percentage: 0%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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