Regulatory Compliance Commercial Specialist - temporary

• Contract
• Shift: Day
• Ways of Working:
  Onsite - This job is fully onsite.
• Employee Type:
  Contractor
• Global Job Level (HCM):
  Support 1 (1)

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Primary Function of Position:

Role with European scope. Under the supervision of Director RCC, the RCC Specialist will coordinate and ensure timely execution and consistency of routine and cross-functional compliance activities. She/He will act as a subject-matter contributor, ensuring regulatory compliance and advising commercial teams. She/he will play a key role in ensuring compliance with the EU Medical Device Regulation (EU MDR), Swiss Medical Devices Ordinance (Swiss MedDO) and pertinent regulatory frameworks by following established processes.

Roles and Responsibilities:

Routine / Operations:

• Independently manage customer regulatory inquiries and tender support within defined scope
• Perform product compliance verification and document regulatory assessments
• Support review of commercial customer communications
• Manage Economic Operator notifications and escalation to manufacturer
• Perform regulatory surveillance activities, including impact assessments and communication to stakeholders (Corporate and SMEs)
• Support site KPIs and management review inputs
• Actively support audits and inspections
• Act as technical Manager (when applicable)

Compliance & QMS:

• Own local compliance processes within assigned scope
• Maintain Economic Operator records and registrations
• Support Quality Agreement execution, implementation and tracking for EU service providers
• Execute EU commercial QMS activities (procedures, support, internal audits)
• Ensure timely closure and documentation of assigned compliance activities

Business Support:

• Lead regulatory activities for product lifecycle processes
• Act as RAQA binôme for assigned commercial functions
• Participate in field activities to identify compliance gaps
• Support customer relationship management and issue resolution

Required Knowledge, Skills, and

Experience:

• At least 4+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
• A Bachelor degree, Engineering or Master’s degree in medical…