Position Title: Sr. Regulatory Affairs Specialist

Summary:

This position reports to the Sr. Manager of Regulatory Affairs, and is responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets. The Sr. Regulatory Affairs Specialists works with the regulatory and clinical teams to develop and implement regulatory and clinical strategy to get precision robotic systems through various regulatory agencies.

Primary Responsibilities:

• Work with the Sr Manager of Regulatory Affairs to determine effective regulatory strategies across a variety of projects and issues
• Work independently prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
• Advise company stakeholders on regulatory strategy as part of the product development process
• Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
• Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
• Review and approve Engineering Change Orders in accordance with regulatory requirements
• Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
• Review and approve test protocols to support regulatory submissions
• Review device labeling and advertising material for compliance with submissions
• Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
• Maintain regulatory files
• Perform internal audits of the Quality System
• Analyze product complaints and make recommendations regarding their reportability
• Other duties as assigned

Qualifications:

• Bachelor’s in Engineering or Science required. Advanced degree preferred.
• At least 3 years of experience in regulatory affairs in the medical device, biotech or pharmaceutical environment
• Regulatory compliance experience in the medical device area preferred
• Knowledge of applicable US and EU medical device regulations required. Knowledge of other markets is preferred
• Regulatory submission experience in US and EU, including but not limited to 510(k), PMA, DeNovo, Technical Files, STED
• Working knowledge of GMPs and GCPs required
• Strong written, oral, and interpersonal communication skills including proficient knowledge of regulatory terminology; additional knowledge of medical terminology desired
• Proficiency in MS Office applications: Word, Excel, PowerPoint; web-based applications; Adobe Acrobat