Senior Regulatory Affairs Specialist (Hybrid)

Work Flexibility: Hybrid

As the Senior Regulatory Affairs Specialist, you will support new product development and sustaining activities for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will support the product lifecycle by assessing changes made to the device post launch to determine potential regulatory impact the current clearance.

What you will do

• Assess regulatory landscape to create the development of global regulatory strategies

• Identify requirements and anticipate regulatory obstacles for market access distribution and update regulatory strategy based on changes.

• Determine requirements and options for regulatory submission, approval pathways, and compliance activities.

• Provide regulatory information and guidance during product development, planning, and review proposed product claims/labeling throughout the product lifecycle.

• Work with regulatory authorities and tracks review progress through clear communication.

• Identify the need for new regulatory procedures, SOPs, and helps train stakeholders to ensure organization-wide compliance.

• Prepare and submit electronic submissions, ensuring consistency with regulatory requirements.

What you need

Required

• Bachelors in Engineering, Science, or related

• 3+ years of experience in medical device regulatory affairs and/or quality assurance

Preferred

• Masters in Regulatory Affairs or Regulatory Science

• RAC(s)

Travel Percentage: 10%

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.