Senior Regulatory Affairs Specialist - Temporary position

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:

 

The Sr Regulatory Affairs Specialist is responsible for obtaining and maintaining regulatory clearances and market access for the company’s Medical Devices by demonstrating compliance with applicable regulations through the compilation, submission and management of registration dossiers. This includes leading the preparation and coordination of complex regulatory submissions, representing the company’s regulatory strategy with relevant authorities, and providing expert guidance and advice to cross-functional teams throughout internal processes.

 

 

Roles and Responsibilities:

 

Main activities

• Directs the preparation and coordination of comprehensive regulatory submissions for Medical Devices, ensuring compliance with local and international regulations and achieving company objectives and timelines
• Leads the compilation of all materials required for regulatory submissions, renewals and annual registrations
• Represents the company's regulatory strategy with Notified Bodies and other Competent Authorities, builds and maintains positive relationships with them
• Provides expert guidance and advice to cross-functional teams on interpreting and communicating complex regulatory concepts and requirements
• Keeps abreast of changes in regulations and standards and proactively adapts company policies and procedures accordingly
• Leads process improvement initiatives to streamline and optimize the regulatory process and procedures
• Contributes to the creation of regulatory strategy and plans to support the development and commercialization of new products
• Supports the development and training of team members and contributes to the continuous improvement of the Regulatory Affairs department.

Additional activities

• Assists in the implementation and maintenance of the Quality Management System, such as CAPA, Management Review and audits
• Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations
• Reviews and approves labeling, advertising and promotional materials to ensure compliance with regulatory requirements
• Provides regulatory support to other departments such as R&D, engineering and clinical affairs as needed
• Other regulatory tasks and projects may be assigned as necessary.

Qualifications

Required Knowledge, Skills, and Experience:

• At least 8+ years of significant experience in regulatory affairs and quality compliance for medical devices according to EU regulation
• A Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
• In-depth knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive (93/42/EEC) and Regulation (2017/745/EU)
• Significant experience in design control, including new product development
• Knowledge of product EU regulations or directives (e.g. RED, ROHS, Waste Framework, …)
• Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams
• Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C1 minimum) in written and spoken English
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)

Preferred Knowledge, Skills, and Experience:

• Knowledge of US FDA 21 CFR 820.30 and 510(k)

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.