Sr. Regulatory Affairs Operations Specialist

Responsible for leading process improvement efforts across the Regulatory Affairs department in the areas of regulatory submissions, regulatory impact assessments, licenses, and other tasks to comply with applicable state, federal, and international regulations. Responsible for leading the global management of medical device standards, regulations, and guidance documents applicable to the organization’s Neurovascular products and Quality Management System.
Represent Regulatory Affairs in cross-functional projects to improve operational elements of the business.

Job duties:

• Serve on business and department projects for process/system updates and implementations.
• Assess existing processes within regulatory affairs to identify opportunities for improvement. Create strategies and implement solutions to improve the quality and efficiency of regulatory tasks.
• Serve as Regulatory Affairs SME for system requirements and responsible for maintenance of applicable systems to support regulatory activities.
• Ensure compliance with regulations pertaining to site establishment registrations, certificates, and licensing.
• Support global monitoring, assessment, and communication of evolving medical device regulations and standards, maintaining accurate standards databases and ensuring timely impact evaluation across product, QMS, and documentation processes.
• Coordinate cross-functional implementation of new or updated standards by partnering with RA, Quality, R&D, and Operations to maintain audit-ready compliance records, drive documentation updates, and support readiness for notified body and internal audits.
• Maintain regulatory files and records.
• Responsible for establishing regulatory procedures and processes as needed, initiating updates as necessary in a regulated environment.
• Build team cohesiveness by influencing and supporting team members.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Job  

Salary Range:

$91,628 - $120,263 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

• Bachelor's degree in a scientific or technical discipline or relevant field of study.
• Minimum four (4) years of relevant professional regulatory experience, including industry related processes (QMS, supply chain, and IT applications and infrastructure).
• Working knowledge and experience with Windchill PLM or other document management systems used in the medical device industry.
• Excellent written and verbal communication skills.
• Proficient computer skills including MS Word, Excel, Outlook, and Teams.

• Advanced degree in a scientific or technical discipline or relevant field of study.
• Ability to work well in a team environment.
• Strong understanding of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485, MDSAP, PMDA, ANVISA, Health Canada, etc.)
• Proven analytical, organizational, and project management skills. Able to efficiently manage multiple projects and priorities.
• Extensive knowledge in configuration and management of industry specific systems (e.g., PLM, SAP, RIMS, etc.).
• Proficient with SharePoint, Adobe Acrobat, Monday, ASANA, etc.
• Ability to quickly learn new computer technology software packages.