Job DescriptionPOSITION SUMMARY:The Senior Regulatory Affairs Specialist II will report to the Director of Regulatory Affairs and will work with Product Development, Quality, Operations, and Marketing to support the product development process and meeting all applicable regulatory requirements. The Senior Regulatory Affairs Specialist II will work with Marketing, Sales, Legal and Regulatory partners on advertising and promotional materials as well as product labelling while meeting all applicable regulatory requirements. The Senior Regulatory Affairs Specialist II will support daily regulatory operations and regulatory data management as well as monitor and assess applicable regulatory landscape changes.
PRIMARY DUTIES AND RESPONSIBILITIES:- Serves as the Regulatory representative providing regulatory guidance to product development and sustaining project teams.
- Authors US FDA premarket submissions (e.g., 510(k), Q-submissions) and international submissions with collaboration from key staff in Product Development, Operations, Marketing, and Quality for timely submissions.
- Serves as primary contact for regulatory agencies on assigned submissions and negotiates submission data requirements and deliverables with regulatory authorities and product development teams for timely clearance.
- Authors regulatory assessments for proposed changes to products or processes.
- Collaborates with Marketing, Sales, Legal and Regulatory partners for timely review of advertising and promotional materials as well as product labeling.
- Monitors regulatory landscape changes and authors impact assessments to key proposed or issued regulatory guidance, directives, and legislation. Interprets changes for implementation into TMC processes.
- Maintains US FDA and international registrations and device listings.
- Supports the Unique Device Identifier (UDI) requirements including US FDA Global Unique Device Identification Database (GUDID) and international UDI submissions.
- Maintains regulatory data, files, and daily regulatory operations.
- Participates in audits by regulatory authorities, certification bodies, or internal auditors.
- Mentors junior Regulatory staff and guides for cross-functional understanding of applicable regulatory requirements and processes.
- Develops and implements new Regulatory processes and procedures and conducts Regulatory trainings for departmental and cross-functional understanding of regulatory requirements and procedures.
QualificationsMINIMUM REQUIREMENTS:Education and Experience:- Bachelor's degree in Engineering, Science, or relevant technical discipline is required.
- Minimum of 7 years of Regulatory Affairs related experience in a medically regulated environment with at least 5 years in a medical device company (US FDA Class II) is required.
- Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred.
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