Compliance Specialist 3

Primary Function of Position:

The primary function of this position is to coordinate and assist field action strategy team related activities. They are to possess an effective understanding of the field action process. They responsible in making sure the field action are executed in a timely manner by collecting all the necessary information needed to execute. The analyst will work closely with cross functional teams to ensure that execution of the field action is complaint and is within approved processes. On top of managing day to day activities for executing field actions the analyst will also assist in providing historical field action data for requests coming in to the field action team. The analyst will also be expected to assist the team in record retention based on company and regulatory standards. If needed the analyst will also act as a field action subject matter expert to provide guidance to other teams.

Roles & Responsibilities:

• Assist with the Product Correction and Removal process
• Provide applicable data for field removals field upgrades tracking of customer notifications field service repairs and maintenance of correction documentation.
• Conduct Global Field Action assessments (product return status with competent authorities) for world-wide field actions
• Support group meetings to review open tasks provide updates and ensure that all tasks have been assigned
• Compile and maintain recall related paper and electronic records
• Assist in recall reporting and assist in the timely initiation and communication of recalls
• Support internal and external audits for recalls as established necessary by management.
• Provide manufacturing and product development with the necessary information to assess relative to product quality
• Assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.e. 21CFR 806 & part 7 CMDR MEDDEV 2.12-1 etc.)
• Create and review ECOs as needed
• Prepare PIR summaries and reports for presentation to the PIR forum for review and maintaining documentation in accordance with department policies procedures and work instructions
• Compile monitor and report on trending of pertinent metrics as required
• Drive meetings for progress updates with global teams
• Manage kick off meetings (FAST) for new field actions
• Create customer response letters upon request
• Participate in new hire training and continuous Regulatory Compliance training as required
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Create and submit formal field action report for FDA Health Canada and distributors.
• Including monthly reports and closure requests.
• Assist in the backroom during audits and prep folders
• Maintain audit ready resources (field action binders)
• Manage the DVKB system and Trackwise
• Track reconcile follow up and file RMA returns and acknowledgements from customer sites
• Work on legal request provided related to Field Actions

Qualifications :

Skills Experience Education & Training:

• Bachelors Degree
• 4 years of experience in medical device field with experience in the following areas:
• Knowledge and understanding with Medical Device field actions and quality record documentation
• Knowledge and understanding of Regulatory reporting requirements for Medical Devices in the field action space (US FDA requirements EU MDD requirements etc.)
• Self-guided and lead with limited assistance needed for executing field actions from beginning to end
• Demonstrate proven written and verbal communication skills
• Effective computer skills (Excel Word PowerPoint database)
• Efficient autonomous worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload autonomously
• Prioritize numerous activities in a rapid paced environment
• Contribute to team oriented tasks
• Proven analytical skills
• Excellent interpersonal and decision making skills.
• Ability to maintain professionalism in all types of environments.
• Effective interpersonal and organizational skills with meticulous attention to detail.
• Must be able to work successfully within a team environment and autonomously

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Full-time