Associate Medical Officer – Regulatory Affairs

Intuitive seeks a forward-thinking robotic surgeon with regulatory experience to play a pivotal role in developing strategies for expanding indications on existing and new robotic surgery platforms and products.  This unique opportunity allows a practicing surgeon to blend their clinical expertise with a part-time position as an Associate Medical Officer to provide a surgeons perspective on strategies to obtain regulatory clearances to expand indications in the US as well as OUS helping regulation clinical requirements in Europe or APAC for new market entries and indications development.  This highly visible position will work within the Regulatory Department and drive cross-functional teams consisting of clinical affairs surgical applications human factors and other groups to effectively develop bench testing clinical evidence and labeling for expanding indications.

This successful candidate will represent Regulatory Affairs in clinical evidence generation activities and establish a real-world evidence and clinical data framework for helping global indication expansions.  This role will work with our global regulatory affiliates on strategies for obtaining desired indications in our global markets.  This person will develop of the complexities of the organizations regulatory and evidence generation processes and facilitate solutions for expanding indications worldwide.  This position necessitates close partnership with various internal departments within Intuitive including Product Development Product Management Surgical Applications Engineering Clinical Affairs Training and Education and Global Market Access teams underscoring the cross-functional nature of this impactful role.

CORE RESPONSIBILITIES:

• Manage strategies for expanding indications to help Business Unit priorities

• Steer the development of comprehensive bench and clinical evidence strategies to efficiently obtain regulatory authorizations for expanding indications

• Coordinate extensively Clinical Affairs to help clinical studies and regulatory filings for Investigational Device Exemption studies

• Develop relationships and supervise regulatory input to cross-functional clinical evidence activities with Clinical Affairs Product Management and Market Access groups as a major cross-functional collaborator

• Establish real-world evidence and clinical data repository for Regulatory Affairs and provide insights on the potential use of this evidence for helping global regulatory submissions

• Work closely with regulatory leadership and promote awareness of clinical evidence and projects and provide strategic input to global indication expansion projects

• Leverage a deep expertise of existing medical literature to contextualize and enhance the interpretation of findings from clinical studies for expanding indications

• Assist in the identification of qualified investigators the development of robust study protocols and the design of scientifically sound studies intended for regulatory submissions

Qualifications :

CORE SKILLS & COMPETENCIES:

• MD with a minimum 10 years experience preferably with some experience in robotic surgery

• Expert knowledge of applicable rules regulations and guidance related to premarket submissions including Investigational Device Exemption clinical studies

• Ability to build consensus and to negotiate a favorable position for the company

• Expertise interacting with regulatory agencies including leading meetings with regulatory agencies

• Proven track record of effective partnership with regulatory agencies e.g. successful clearances and meeting deadlines for submissions in a least burdensome manner

• Capability of building solid relationships with internal and global partners considering language and cultural differences

• High capacity and ability to interact with multiple teams various complex tasks and projects and highly visible and impactful assignments

• Excellent communication (written verbal) presentation and documentation skills with multiple levels of leadership

• Exceptional interpersonal skills and excellent ability to work well with cross-functional teams

• Self-managed needing minimal supervision to get things done effectively

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.

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