Sr. Regulatory Affairs Specialist

Position Summary

The Senior Regulatory Affairs Specialist will focus on the regulatory activities and deliverables to strategically assess and support related regulatory tasks including simple to complex submission writing. This role will be responsible for strategy and facilitating compliant, streamlined execution of regulatory affairs activities related to implementation of multi-business unit operations initiatives. This role is responsible for effectively partnering with PM RA, Regional RA, Reg Ops and cross-functional teams and a varied group of stakeholders to aide in regulatory strategy and execution for operations programs.

Principal Responsibilities

• Develop and execute comprehensive regulatory strategies for new and modified products, including PMA, IDE, 510(k), MDR Technical Documentation, and Health Canada submissions, ensuring compliance with US, EU, and Canadian regulations.
• Conduct regulatory research and assessments using applicable standards, guidance documents, and prior approvals to support sound regulatory decision-making across Business Units.
• Partner with Regional and Business Unit Regulatory Affairs to develop and implement global registration strategies, ensuring alignment on deliverables and timelines.
• Collaborate with cross-functional teams—including Quality, Engineering, Operations, Sterilization, Biocompatibility, and Manufacturing—to manage regulatory activities, maintain compliance, and meet project milestones.
• Interact and negotiate with regulatory authorities and Notified Bodies to support product lifecycle management, including FDA pre-submission meetings, PMA/510(k) filings, Health Canada submissions, and EU MDR Technical Documentation.
• Review and assess change control activities, risk management documentation, and design control deliverables to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory input for post-market surveillance activities, labeling, and promotional material review to ensure claims are accurate and compliant.
• Support and prepare for regulatory agency and Notified Body audits, maintaining accurate and inspection-ready documentation.
• Identify and communicate potential regulatory risks, propose mitigation strategies, and recommend process improvements to enhance compliance and operational efficiency.
• Monitor evolving global regulatory requirements and communicate key changes and impacts to internal stakeholders.
• Contribute to continuous improvement initiatives within Regulatory Operations, including updates to departmental procedures and documentation practices.

Education / Experience Requirements

• Bachelor Degree in Science or Engineering disciplines.
• Minimum 5+ years of experience working within medical device industry; 3+ years with Class II or higher registrations.
• Knowledge and understanding of US, EU and Canada medical device regulations, standards, and guidance documents.
• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
• Excellent technical writing experience within a medical device environment – essential
• Attention to detail and accuracy – essential
• Fluent in English, both written and oral – essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management

Specialized Skills / Other Requirements

• Highly organized with strong attention to detail and ability to prioritize multiple tasks.
• Self-starter who takes initiative and follows through on written and verbal instructions.
• Excellent written and verbal communication skills with strong cross-functional collaboration.
• Skilled in proofreading technical documentation for accuracy and consistency.
• Demonstrated problem-solving ability; adaptable to shifting priorities and changing project needs.
• Proficient in Microsoft Office (Excel, Word, PowerPoint) and statistical or analytical software.
• Knowledge of Corrective Action, Manufacturing, and Design Control concepts preferred.
• Positive, proactive, and effective in working across teams and with leadership