- 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.
- 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.
- 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)
- Knowledge of US FDA 21 CFR and 510(k)
-
Regulatory Affairs Specialist
vor 3 Tagen
Intuitive Aubonne, Schweiz GanztagsCompany 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 ...
-
Regulatory Affairs Specialist
vor 5 Tagen
Intuitive Surgical Aubonne, Schweiz EmployeeCompany 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 ...
-
Senior Regulatory Affairs Specialist
vor 5 Tagen
Intuitive Aubonne, Schweiz GanztagsCompany 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 ...
-
Senior Regulatory Affairs Specialist
vor 6 Tagen
Michael Page Geneva, Schweiz GanztagsProvide Regulatory strategies for projects as RA representative in cross-functional teams · Responsible for regulatory Assessment on product changes · Coordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements)in the context of new product and ...
-
Legal Affairs Specialist o/p Geneva
vor 1 Woche
UNICEF Geneva, SchweizUNICEF · UNICEF works in over 190 countries and territories to save children's lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. · At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of ...
-
WTO Geneva, Schweiz· Trade policy analysts/specialists and legal/economic affairs officers work in various divisions of the WTO Secretariat. In addition to providing specialist advice in their respective divisions, they provide support to bodies serviced by WTO divisions (e.g. committees, working ...
-
Regulatory Affairs OTC Category Manager
vor 2 Tagen
Haleon Nyon, SchweizThe purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative r ...
-
Director, Clinical Operations
vor 1 Woche
Proclinical Lausanne, SchweizAn opporutnity has opened for a Director, Clinical Operations to join a fantastic, medium sized Pharmaceutical company based in Lausanne, Switzerland. You'll be joining this company at a significant time of growth where you'll manage cross functional Study Teams globally, whilst ...
-
Regulatory Affairs
vor 1 Woche
MANE SA Vouvry, Schweiz**Job summary**: · Within the Regulatory Affairs and Product Safety Department, you will be supporting the regulatory affairs specialists for the customer care to provide gold standard services to our valued customers: · - Prepare regulatory documents within timelines agreed with ...
-
Master's Thesis
vor 1 Tag
PICTET Geneve, Schweiz**Your team**: · - The Pictet Group is one of the world's leading independent wealth and asset managers. Founded in 1805 and headquartered in Geneva, Switzerland, the Group is represented at 30 offices in financial centres worldwide, currently employing over 5000 people.Pictet We ...
-
Junior Client Relationship Manager
vor 1 Woche
Finders SA Geneve, Schweiz**Client**: · A leading, global multi family office offering a close-knit, collegial, fast-paced Geneva office team to join. · **Position**: · Are you a worker bee, hungry and driven for a new challenge? · A client that Finders know intimately so can help explain the culture to a ...
-
Training Assistant
vor 1 Woche
UNITAR Geneve, SchweizDuration of the contract · - 1 year (renewable) · - 12 April 2024 · - Organizational Unit · - Multilateral Diplomacy Programme Unit (MDPU) · - Remuneration · - CHF 5000/month · - Number of job positions · - 1 · - Background: · In an increasingly globalized world, where the import ...
-
Trade Expert and Regional Coordinator
vor 9 Stunden
United Nations Geneve, SchweizResult of Service · The consultancy will lead the implementation of: · - The MSG Green Trade Project through the development of synergistic linkages between green trade promotion and national sustainable development strategies at national level and the strengthening of the MSG mu ...
-
Intuitive Surgical Aubonne, Schweiz TempCompany 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 ...
-
Intuitive Aubonne, Schweiz GanztagsCompany 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 ...
-
RA & QA Compliance Specialist
vor 1 Woche
Randstad Morges, SchweizJobdescription · Are you ready to dive into the world of RegulatoryAffairs and Quality Assurance ? We're on the lookout for a RA &QA Compliance Specialist to join a dynamic team and medical devicecompany · We are seeking aqualified candidate for the role of Regulatory Affairs an ...
-
RA & QA Compliance Specialist
vor 6 Tagen
Randstad Lausanne, Schweiz TEMPORARYAre you ready to dive into the world of Regulatory Affairs and Quality Assurance ? We're on the lookout for a RA & QA Compliance Specialist to join a dynamic team and medical device company · We are seeking a qualified candidate for the role of Regulatory Affairs and Quality Ass ...
-
QMS specialist
vor 4 Tagen
Novostia Epalinges, SchweizNovostia is a clinical stage company founded in April 2017, in Switzerland, that is developing a breakthrough heart valve prosthesis offering superior benefits and quality of life to young adults and elderly people suffering from heart valve disease. · QMS specialist · The QA Spe ...
-
Regulatory Affairs OTC Category Manager
vor 2 Tagen
Haleon Nyon, Schweiz GanztagsThe purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative r ...
-
Media Counsel
vor 3 Tagen
Alec Allan & Associés Geneva, SchweizOn behalf of one of our clients, an international sports organization based in the French-speaking part of Switzerland, we are seeking a: · Media Counsel · Responsibilities · Fulfil the role of a subject matter specialist and support business and legal teams, including TV, Marke ...
Senior Regulatory Affairs Specialist - Aubonne, Schweiz - Intuitive Surgical
Beschreibung
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
Additional activities
Qualifications
Required Knowledge, Skills, and Experience:
Preferred Knowledge, Skills, and Experience:
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.
Shift: Day
Travel: None
