Sr Regulatory Affairs Specialist

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 theirmost 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

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.

Primary Function of Position:

The Sr Regulatory Affairs Specialist is responsible for ensuring medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier.

Roles and Responsibilities:

Main activities

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  Directs or performs coordination and preparation of document packages for complex medical device regulatory submissions based on company objectives and timelines as well as known and unknown factors
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  Leads or compiles all materials required in submissions, license renewal and annual registrations
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  Represents Intuitive’s regulatory strategy with Notified Body or other competent authorities
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  Provides influential presentations/advices for changes to regulatory strategy, labeling, manufacturing, marketing, and clinical protocol to achieve regulatory compliance.
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  Represents RA interests with internal marketing partners to drive compliance adherence by translating complex regulatory concepts into understandable principles
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  Independently advises cross-functional teams and share knowledge and expertise to support development and training of team members

Additional activities

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  Implements and supports Quality Management system activities such as CAPA, management review and internal & external audits as needed
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  Ensures that company procedures, processes and documentation meet requirements of the Quality Management System, ISO 13485 and other applicable regulations
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  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
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  A Bachelors or Master’s degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
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  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)
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  Significant experience in design control, including new product development
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  Knowledge of product EU regulations or directives (e.g. RED, ROHS, Waste Framework, …)
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  Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results
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  Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams
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  Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
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  Orientation for work result details, with emphasis on accuracy and completeness
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  Fluent (C1 minimum) in written and spoken English
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  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.