Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Job Location: Remote PST Hours

Job Duration: LongTerm

Primary Function of Position:

• The Regulatory Standards Management (RSM) Specialist works closely with the RSM Manager and team to surveil assess and integrate Standards and Regulations applicable to Intuitive.
• The Specialist maintains process documentation and logs and generates metrics and other reports to help internalize global regulations and meet compliance targets for completion of Regulatory Surveillance Assessments and Integration Handoff activities.
• The RSM Specialist is responsible for executing activities associated with Initiatives RSM Process and other company procedures to create and maintain records and logs for Regulatory Surveillance processes as follows.

Roles & Responsibilities :

• Receives and compiles information from Global Surveillance activities.
• Maintains publications per DOP Process for External Standards Library. Initiates External Standards Forms in Agile (ACCS) as needed
• Requests translations through internal processes as needed
• Initiates Assessment Forms and tracks SME assignments.
• Performs closures as appropriate.
• Reviews completed Assessments for completeness and accuracy.
• Liaises SME and RA to facilitate completion of assessments. Incumbent works closely with the local process owners and business partners ensure RSM procedures are followed and appropriate evidence/record is established.
• Confirms RSA assignments with SME.
• Negotiates RSA due dates and extensions.
• Provides reminders and status updates upon request.
• Compiles and reports process metrics and KPIs; provides periodic process timeliness reports and reminders to SMEs to help keep assessment and Implementation activities ontarget.
• Updates and maintains all aspects of the Standards Database and information necessary for Intuitives local functions and circulation of such information as required. Partners with process owners to ensure assessment identification of and adherence to requirements and process.
• Prepares periodic updates as required by leadership and management forums (i.e. Quality Review Board (QRB) Management Review etc.)
• RSM specialist will support internal and external Quality System audits and will report relevant information on periodic basis.
• Other activities as identified by RSM management.

Skills Experience Education & Training:

• Bachelors or higher or equivalent work experienced required.
• Familiarity with quality management systems such as ISO 9001 and ISO 13485.
• Computer literacy (PC Microsoft Word/Excel/PowerPoint Access Outlook) experience with Agile PLM a plus.
• Facility with Smartsheet MSEXCEL charts and data functions (Filter Sort COUNTIFS) MSWORD (Mail merge capability a plus)
• Facility with Agile or similar Automated Change Control System (Search Monitor workflows of existing change orders. The ability to create change orders (completing title page upload document and run approval matrix) is a plus.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
• Demonstrated organizational and planning skills including actionoriented focused urgency and driving for results.
• Strong interpersonal skills ability to work with others in team environment effective interactions in cross department teams.
• Strong Project management skills (e.g. administrative WBS and record keeping)
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
• Detail orientated with emphasis on accuracy and completeness.
• Ability to travel up to 10% dependent on project alignments with other sites.
• Strong written and oral communication skills.