Senior Regulatory Affairs Specialist

The Regulatory Affairs Specialist will ensure Robotic Assisted Surgical Device regulatory requirements are met for marketing products in local and strategic international markets Further, this role provides strong project management leadership for medical device regulatory submissions, registrations, and internal policy and procedures needed for compliance to international standards and regulations. Internally, this position interacts with all functions (e.g. engineering, quality, sales, marketing, procurement and manufacturing) and will work with all levels (e.g. management and support staff). Externally, this position interacts with regulatory agencies, distributors, consultants, customers, partners, and vendors.

• Manage regulatory files and databases to ensure prompt and accurate access to regulatory information and provide reports to Management concerning current, pending, and future registration activities.
• Prepare and assemble documentation for product or facility registrations in local or international markets, as requested.
• Develop and recommend strategies for earliest possible approvals of device applications.
• Assess impact of documentation delays, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
• Interpret Regulatory Agency requests and correctly apply them as appropriate for assigned devices.
• Assess new and/or modified standards, regulations / laws and determine applicability to the organization and/or product
• Ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements
• Work effectively with cross-functional staff across multiple sites as well as external partners.
• Contribute to preparing for external audits and provide support during audits.
• Review change requests for packaging, literature, work instructions/procedures, production BOM/routers and other controlled document for regulatory compliance
• Represent the regulatory function for new product development projects, as assigned
• Participate in other activities as needed, e.g. post-market surveillance, training, export documentation, document legalization etc

Requirements:

Experience in FDA regulated industry Surgical Robotics

Knowledge of ISO 13485 and quality system principles

Ability to apply risk-benefit analysis techniques.

Ability to interpret technical documentation.

The ability to write and edit technical product documentation