Senior RAQA Manager

Company Description

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 market leader in 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.

Job Description

Primary Function of Position:

Act as a representative of Intuitive Surgical Ltd (UK Responsible Person), importer and distributor under the UK medical device regulations. Management of regulatory operations, post-market surveillance, QMS, liaison with Corporate & global RAQA teams, advocacy with government bodies and manufacturer associations across assigned markets (Especially UK and Ireland). Ensure proper liaison with sales, marketing and service teams as well as all other enabling functions.

Roles and Responsibilities:

Regulatory Compliance & Quality System

• Fulfill the role of UK Responsible Person contact and site management representative
• Responsible for ensuring compliance of the quality system activities (Nonconformance management, audit/inspection, economic operator obligations, post market surveillance) in the target markets
• Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
• Stay informed about regional regulatory changes and updates, and implement necessary adjustments to the QMS.

Business Support

• Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly
• Represent Intuitive Surgical with competent authorities (eg MHRA, HPRA) and manufacturer associations (eg ABHI, IBEC) to develop and strengthen partnerships, and monitor and implement regulatory trends
• Support public procurement activities and customer satisfaction by ensuring timely and accurate RAQA input

Additional activities

• Other projects may be assigned as necessary
• Travel: up to 20%

Qualifications

Required Knowledge, Skills, and Experience:

• At least 8+ 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 technology, life sciences or similar (or equivalent work experience in similar function)
• Deep knowledge of EU MDR 2017/745/EU, UK MDR 2002 and ISO 13485:2016
• Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
• Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
• Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
• Orientation for work result details, with emphasis on accuracy and completeness
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
• Language: Fluent English

Preferred Knowledge, Skills, and Experience:

• Lead auditor certification for ISO 13485 and knowledge of WW regulations
• RAC certification is a plus
• Team management experience of small team size associated with goals objectives definition / people development.

Additional Information

Intuitive is an Equal Employment 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.