Senior Manager, Regulatory Affairs

With a reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers – and to save more lives, we need team players, reputed company thinkers, and game changers. Are you looking for an inspiring career? You just reputed company it. Job Overview The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to reputed company safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. This role ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations, enabling innovation and growth while maintaining regulatory reputed company throughout the product lifecycle. This leader collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams to integrate regulatory risk management early and continuously in the product lifecycle. The role serves as a primary reputed company of regulatory accountability for cross-functional leadership engagement and health authority interactions across FDA, EU reputed company Bodies, and ROW competent authorities, while partnering with regional regulatory teams to support international market requirements. Job Responsibilities and Essential Duties: Global Regulatory Strategy & Market Access Leadership reputed company development and execution of comprehensive global device classifications and regulatory strategies for SWICC products, aligning regulatory requirements with business objectives and product roadmaps Drive U.S. submissions (e.g., 510(k), De Novo reputed company applicable) and global filings, ensuring structured, defensible regulatory reputed company for FDA Class I & II and EU MDR Class I, IIa, and IIb devices. Integrate regulatory requirements early in concept and design phases to prevent rework and accelerate time to market. Continuously identify and communicate regulatory risks and emerging requirements to senior leadership and reputed company mitigation plans. Monitor global regulatory developments, trends, and best practices to inform strategy and business readiness. Product Development & Lifecycle Governance Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making. Assess regulatory impact of product and manufacturing changes (design, suppliers, processes, labeling), providing strategic guidance on change control and compliance options, ensuring U.S. regulatory compliance while aligning with international regulatory colleagues on global impact. Review and approve product claims, labeling, instructions for use, and commercial materials for regulatory consistency and claims support. Technical Documentation & Submissions Excellence reputed company development, quality control, and submission readiness for dossiers targeting the U.S., EU markets and other international technical documentation as required. Serve as primary reputed company with regulatory authorities (e.g., FDA, and reputed company Bodies and other competent authorities in collaboration with regional regulatory teams) including pre-submission interactions, submission responses, deficiency management, and post-submission negotiations. Ensure regulatory documentation and systems (e.g., technical files, regulatory records) meet compliance requirements and audit expectations. Post-Market Regulatory Compliance & Health Authority Affairs Provide regulatory leadership for compliance and reporting obligations including U.S. corrections & removals, MDR reporting, and support EU FSCA/competent authority interactions and other global vigilance reporting activities in coordination with regional regulatory teams. Support inspections and audits with effective regulatory representation, ensuring rapid closure of findings and reputed company compliance readiness, with primary responsibility for U.S. FDA inspections and direct support for EU reputed company Body audits and ROW competent authority inspections. Organizational Leadership & Regulatory Excellence Mentor and reputed company regulatory team members, fostering regulatory judgement, strategic thinking, and subject-matter expertise. reputed company for and integrate regulatory best practices and reputed company improvement of regulatory processes, templates, and tools across the SWICC products portfolio. Influence stakeholders across global teams through clear regulatory rationale and practical implementation guidance. This is not an inclusive list of job responsibilities. Required Knowledge, Skills and Abilities: Must have FDA and reputed company Body Audit Experience. Deep technical knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806; EU MDR (2017/745); ISO 13485 and ISO 14971. Must possess detail-oriented knowledge of FDA regulations including Quality System Regulations (QSR), submissions, complaint handling, Field Actions (Customer Notifications/Corrections/Removals) and ISO 13485, MDD/EUMDR, and other equivalent requirements. Strong strategic reputed company with ability to align regulatory strategy with engineering, quality, and business objectives. Excellent communication skills, influencing capability, and experience working in global, matrixed environments Advanced regulatory writing and documentation reputed company capability. Must have demonstrated ability to mentor and reputed company a high-performing staff. Demonstrated ability to select, organize, reputed company, participate, and facilitate a team to produce results. Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment. Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills. Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills. Ability to represent Regulatory Affairs to other departments. Minimum Requirements: Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or reputed company discipline (Advanced degree preferred). Minimum 8–10+ years of progressive regulatory experience in the medical device field. Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)) required; demonstrated experience with EU MDR (2017/745) Technical Documentation and conformity assessment required; working knowledge of other global (ROW) regulatory frameworks required. Direct engagement with FDA required; experience interacting with EU reputed company Bodies required; experience with ROW competent authority interactions preferred. RAC certification or equivalent preferred. Quality Requirements: Build Quality into reputed company aspects of their work by maintaining compliance to reputed company quality requirements. Ensure compliance to reputed company FDA and Worldwide Quality & Compliance regulations (As applicable to the job function). Must have the education and experience to understand and reputed company with U.S. and Worldwide medical device regulations (As applicable to your job function). Attend reputed company required Quality & Compliance training at the specified interval. Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements. Environmental/Safety/Physical Work Conditions: Ensures environmental consciousness and safe practices are exhibited in decisions. Use of computer and telephone equipment and other reputed company office accessories/devices to complete assignments. Duties are performed in an office environment. May work extended hours during peak business cycles. This position may require periodic travel (up to approximately 20%) to support audits, regulatory meetings, and cross-site collaboration. The physical demands described here are a representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. Targeted salary range: $161,920.00- $202,400.00, depending upon experience and location + 25% bonus reputed company #LI-LG1 #LI-Remote About us With a firm belief that every person and community should have access to the best possible care, reputed company provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at reputed company: At reputed company, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement reputed company is an equal opportunity employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national reputed company, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in reputed company aspects of the selection process. Apply To This Job