Staff Regulatory Affairs Specialist (Hybrid)

Job description

Work Flexibility

Hybrid Join Stryker's Medical Division supporting Emergency Care as a Staff Regulatory Affairs Specialist based in Redmond, Washington . In this role, you will help guide regulatory activities across product development, product changes, and lifecycle management while partnering with cross-functional teams to provide regulatory guidance and help ensure ongoing compliance and market availability.

What You Will Do

Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed product changes, software updates, and product transfers. Support sustaining regulatory activities across a complex portfolio of products, ensuring ongoing compliance, product availability, and implementation of product and process changes. Identify regulatory requirements and potential barriers to market access and product distribution.

Develop and refine regulatory strategies in response to product changes and evolving regulatory requirements. Evaluate products for regulatory classification, jurisdiction, and applicable regulatory pathways. Prepare and submit regulatory filings in accordance with applicable regulatory requirements and agency guidelines. Provide regulatory guidance for product development, product lifecycle management, and planned product changes.

Communicate and interact with regulatory authorities throughout submission development, review, and approval activities. Evaluate pre-clinical, clinical, manufacturing, and software changes and recommend appropriate regulatory filing strategies. Maintain product registrations and support required registration updates, reports, and notifications. Support the development of procedures, work instructions, and stakeholder training related to regulatory requirements and compliance activities.

Required Qualifications

Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Affairs, or a related technical field. Minimum 4 years of experience in Regulatory Affairs within a medical device, pharmaceutical, biotechnology, or other highly regulated industry. Experience authoring and managing regulatory submissions, registrations, or product approvals.

Preferred Qualifications

Experience with Class II and/or Class III medical devices. Experience supporting Software as a Medical Device (SaMD) products. Experience developing regulatory strategies for product development, lifecycle management, or product transfer activities. Regulatory Affairs Certification (RAC) and/or master's degree in Regulatory Affairs or a related field. Strong communication skills with the ability to explain regulatory requirements to technical and non-technical stakeholders.

US15

$110,100 - $183,400 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

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.