Senior Specialist Regulatory Affairs

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 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

• Bachelors 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

• Masters 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.

• $95800 - $159600 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 contractors legal duty to furnish information.