Staff Regulatory Affairs Specialist

• 12 months fixed term contract (Hybrid role)****

Key Areas of Responsibility

• Provides regulatory affairs support to the Patient Specific Solutions business to achieve timely approvals of custom devices via custom and compassionate use pathways.
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution.
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Provides regulatory information and guidance for proposed product claims/labeling
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

Education/Work Experience

• BS in Engineering, Science, or related or MSc in Regulatory Science or Clinical Science
• Typically a minimum of 4 years experience
• RAC(s) preferred

Knowledge/Competencies

• Strong project management, writing, coordination, and execution of regulatory items
• Emphasis on technical, clinical and scientific regulatory activities
• Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distribution
• Under general supervision, plans, conducts and supervises assignments
• Reviews progress and evaluates results
• Recommends changes in procedures
• Operates with appreciable latitude for unreviewed action or decision
• Reviews progress with management
• May direct work of Specialist or Sr. Specialist
• Seeks out diverse ideas, opinion, and insights and applies them in the workplace
• Connects and relates well with people who think and act differently than oneself
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
• Navigates the dynamics, alliances, and competing requirements of the organization or business
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Posted Date: 02/04/2026 This role will be posted for a minimum of 3 days. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.