Senior International Regulatory Affairs Coordinator - California, San Jose 5900 Optical Ct

Work Flexibility: Remote or Hybrid or Onsite

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.

Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As a Senior International Regulatory Affairs Coordinator you will be responsible for managing requests for documentation to support global product registration and coordination with Stryker affiliates and other global authorities to facilitate product registration.

• Responsible for developing, coordinating and obtaining legal documentation required for US and global registration including Certificates of Foreign Government, Free Sales Certificates and FDA listing for yearly registration and new product introduction (FURLS administration)

• Builds strong relationships with global regulatory affairs teams and internal cross-functional partners

• Creates strategy around projects to facilitate efficiency or compliance in larger-scale registration projects

• Supports change control notification communication as applicable

• Develops basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures

• Interacting with global content management system (Global RADAR)

• Communicating with internal global regulatory affairs groups

• Uploading change control notification documentation to the content management system (Global RADAR)

• Coordination and support of technical and scientific regulatory activities required for international registration

What you need

• High School diploma or equivalent

• Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred

• 2-5 year’s regulatory experience in the medical device industry.

• Previous experience in legal, technical or medically related area preferred.

• Excellent organizational, problem-solving, and analytical and time management skills

• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

$23.94 - $42.70 per hour plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.