Senior Manager, Regulatory Affairs

Getinge•Fraser, MI

1d•Remote

About The Position

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 enable 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 integrity 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 point of regulatory accountability for cross-functional leadership engagement and health authority interactions across FDA, EU Notified Bodies, and ROW competent authorities, while partnering with regional regulatory teams to support international market requirements.

Requirements

Must have FDA and Notified 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 mindset 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 oversight capability.
Must have demonstrated ability to mentor and develop a high-performing staff.
Demonstrated ability to select, organize, lead, 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.
Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related 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 Notified Bodies required; experience with ROW competent authority interactions preferred.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Nice To Haves

Advanced degree preferred.
RAC certification or equivalent preferred.

Responsibilities

Lead 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 when applicable) and global filings, ensuring structured, defensible regulatory pathways 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 develop mitigation plans.
Monitor global regulatory developments, trends, and best practices to inform strategy and business readiness.
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.
Oversee development, quality control, and submission readiness for dossiers targeting the U.S., EU markets and other international technical documentation as required.
Serve as primary interface with regulatory authorities (e.g., FDA, and Notified 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.
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 continued compliance readiness, with primary responsibility for U.S. FDA inspections and direct support for EU Notified Body audits and ROW competent authority inspections.
Mentor and develop regulatory team members, fostering regulatory judgement, strategic thinking, and subject-matter expertise.
Advocate for and integrate regulatory best practices and continuous 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.