Senior Specialist Regulatory Affairs

Stryker; Irvine (CA); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Stryker in Irvine, CA is seeking a Senior International Regulatory Affairs Specialist to help bring medical technologies to market while ensuring global compliance. You will support regulatory strategy, submissions, and lifecycle activities, partnering with cross-functional teams across product development, quality, clinical, and manufacturing.

The role offers hybrid work flexibility with onsite presence several days per week.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs or related field.
• Minimum 2 years of regulatory affairs experience.
• Experience preparing/regulatory submissions and documentation.
• Experience interpreting regulatory requirements in a regulated environment.

Responsibilities

• Assess regulatory intelligence and requirements to support local, regional, and global strategies.
• Evaluate product, changes, and manufacturing changes for regulatory impact.
• Prepare, compile, and submit regulatory submissions with supporting docs.
• Monitor regulatory review activities and assist with agency communications.
• Provide regulatory guidance to cross-functional teams during development, manufacturing, clinical, and post-market activities.
• Review quality, preclinical, clinical, and manufacturing docs to support submissions and compliance.
• Identify regulatory risks and market access obstacles and propose solutions.

Skills

Regulatory affairs

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs

Job description

Work Flexibility: Hybrid or Onsite

Senior International Regulatory Affairs Specialist

Irvine, CA

Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product lifecycle activities across a range of projects, partnering with cross-functional teams to navigate regulatory requirements and maintain product compliance in global markets.

This position offers the opportunity to contribute to regulatory planning, agency interactions, and submission activities while collaborating with product development, quality, clinical, and manufacturing teams.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Irvine, CA and be able to work onsite several days per week.

What You Will Do

• Assess regulatory intelligence and regulatory requirements to support local, regional, and global regulatory strategies.
• Evaluate products, product changes, and manufacturing changes for regulatory classification, submission requirements, and compliance impact.
• Prepare, compile, and submit regulatory submissions and supporting documentation in accordance with applicable global regulations and guidelines.
• Monitor regulatory authority review activities and support communications with regulatory agencies throughout the submission process.
• Provide regulatory guidance to cross-functional teams throughout product development, manufacturing, clinical, and post-market activities.
• Review quality, preclinical, clinical, and manufacturing documentation to support regulatory submissions and compliance requirements.
• Identify regulatory risks, emerging requirements, and potential market access obstacles, and recommend solutions to support project timelines.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
• Minimum 2 years of experience in Regulatory Affairs.
• Experience preparing, reviewing, or supporting regulatory submissions and regulatory documentation.
• Experience interpreting and applying regulatory requirements within a regulated environment.

Preferred Qualifications

• Master’s degree in Regulatory Science or a related field.
• Regulatory Affairs Certification (RAC).
• Experience supporting global regulatory submissions and regulatory authority interactions.
• Experience working with medical devices or other regulated healthcare products.

Salary

• $95,800 - $159,600 USD Annual

Travel Percentage: 0%

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 Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.