We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Instruments division based hybrid two to three days per week in Portage, MI. **Who we want** · **Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. · **Self-directed initiators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. · **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions. **What you will do** As the **Senior Staff Regulatory Affairs Specialist** , you will support new product development for both domestic and international release contributing to the development and updating of regulatory strategy based upon regulatory changes. You will play an integral role ensuring compliance by completing thorough assessments pertaining to product clearances/approval by the FDA, Notified Bodies, and other regulatory bodies. + Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies + Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature + Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance + Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions + Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.) + 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 + Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization + Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes + 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 + Provides regulatory input and technical guidance on global regulatory requirements to product development teams + 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 + Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions + Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships + Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process + 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 **What you need** + Bachelors Degree required; preferably in Engineering, Science, or related area + RAC preferred + Minimum 6 years of full-time work experience in an FDA regulated environment required + Minimum 4 years of full-time work experience in medical device regulatory affairs required + Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR) Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.