- Lead Regulatory Team efforts in support of NPD projects and sustaining operations within specified Business Units, acting as a primary point of contact for regulatory matters and ensuring regulatory compliance and strategic innovation.
- Develop and communicate comprehensive EU regulatory strategies for projects, guiding team members through the development and implementation process.
- Oversee the preparation and coordination of EU submissions for Medical Devices, securing timely regulatory clearances for new products, new indications, and product changes.
- Mentor team members in the creation and execution of CE Mark submissions and change notifications to our Notified Body (NB), including strategy development for responding to regulatory inquiries.
- Direct the preparation of CE Mark documentation for EU submissions related to NPD projects and product changes, ensuring thorough review before RA Management approval and NB submission.
- Ensure the completion and maintenance of Technical Documentation for CE Mark, adhering to regulatory requirements and best practices.
- Engage with Notified Bodies and Competent Authorities, representing the company's regulatory strategy and fostering positive relationships.
- Offer expert advice to cross-functional teams, interpreting and translating complex regulatory requirements into actionable strategies.
- Stay ahead of regulatory and standards changes, proactively updating company policies and procedures to maintain compliance.
- Initiate and lead process improvement projects to enhance the efficiency and effectiveness of regulatory procedures.
- Support the growth and skill development of team members, contributing significantly to the Regulatory Affairs department's continuous improvement.
- Provide performance review input for Regulatory Affairs Team members, acknowledging contributions and guiding professional development.
- 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
- 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 12+ years of significant experience in regulatory affairs and quality compliance within the medical device sector, with a strong focus on adherence to EU regulations.
- A Bachelor's or Master's degree in Engineering, Medical Technology, or a closely related field is highly preferred, though equivalent practical experience in a similar role may be considered.
- Profound understanding of global medical device regulations, including ISO 13485, the European Medical Device Directive (93/42/EEC), and the Medical Device Regulation (2017/745/EU), ensuring comprehensive compliance across projects.
- Demonstrated ability to independently determine methods and procedures for new or special assignments, coupled with the capability to supervise the work of team members effectively.
- Significant expertise in design control and experience managing EU submissions for NPD projects and sustaining activities.
- Familiarity with specific EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive, among others.
- Demonstrate strong organizational and planning skills, with a proactive approach to problem-solving, a sense of urgency, and a commitment to achieving results.
- Excellent interpersonal abilities, with proven success working collaboratively within international teams and engaging effectively across departments.
- A meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
- Fluent in English, with a minimum of C1 level proficiency in both written and spoken forms, to facilitate clear and effective communication.
- General computer proficiency, including familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook, to support daily operations and communication.
- Knowledge of US FDA 21 CFR and 510(k)
-
Regulatory Affairs Lead
vor 1 Tag
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 ...
-
Regulatory Affairs Director
vor 2 Tagen
SOPHiA GENETICS Rolle, SchweizWould you like to be part of a dynamic and exciting team delivering high level support that has a direct impact on the lives of cancer and rare disease patients worldwide? Do you want to own the regulatory lifecycle of SOPHiA GENETICS product as we pioneer within healthcare? · Br ...
-
Client Account Manager
vor 5 Tagen
UBS Renens, SchweizSuisse - Suisse romande · - Conseil clientèle / Relationship management · - Personal & Corporate Banking · **IdDemandeAuto** · BR · **Ville** · - Renens · **Type de poste** · - Temps plein, Temps partiel · **La fonction** · - Appréciez-vous le contact client ? Gardez-vous la tête ...
-
Client Advisor Private Clients Pfa Renens
vor 5 Tagen
UBS Renens, SchweizSuisse - Suisse romande · - Conseil clientèle / Relationship management · - Personal & Corporate Banking · **IdDemandeAuto** · BR · **Ville** · - Renens · **Type de poste** · - Temps plein, Temps partiel · **La fonction** · - Appréciez-vous le contact client? Gardez-vous la tête ...
-
Director of Regulatory Cmc
vor 1 Tag
Hobson Prior Nyon, Schweiz**Salary**: · Negotiable**Job type**: · Permanent · **Location**: · Nyon, Schweiz · **Function**: · Regulatory Affairs, CMC · **Posted**:05/04/2023 · **Ref**: · BBBH21924 · - Hi I'm · Francecsa · , I manage this role · Hobson Prior are seeking for a Director of Regulatory CMC to ...
-
Junior Legal Counsel
vor 3 Tagen
Nestle Prilly, SchweizCereal Partners Worldwide (CPW) is a leading global breakfast cereal company and the maker of Nestlé breakfast cereals, including global favourites such as NESQUIK,FITNESS, CHEERIOS and CHOCAPIC. With more than 50 brands to suit all ages and lifestyles, we strive to make breakfas ...
-
Market Access Manager Heor
vor 2 Tagen
Edwards Lifesciences Nyon, SchweizBe the strategic partner and provide high-quality health economic and outcomes research analyses and associated activities in evidence generation; synthesize and adapt other data as required to build the value propositions of Edwards's products; support the generation and process ...
-
Quotient Limited Eysins, Schweiz**Posted Date**:17-Feb-2023 · **Location**: Eysins, VD, CH, 1262 · **Company**:Quotient · **DEPARTMENT OVERVIEW**: · The Program Management Offices (PMO) at the two sites in Scotland, UK and Switzerland and their Department leaders report into the Chief Technology Officer of the ...
-
Clinical Research and Biology Affais Associate
vor 5 Tagen
Volumina Medical Lausanne, Schweiz**associate - Pharma/Medical devices · - Full time, 100% · - Based in Lausanne (Biopôle Epalinges and EPFL) - travel time: up to 30% · - 1-year contract, possibly renewable for a total of 2.5 years · Volumina Medical is a start-up, spin-off of the Swiss Federal Institute of Techn ...
-
Legal Counsel
vor 3 Tagen
Haemonetics Corp. Signy-Avenex, SchweizWe are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. · Job Details · JOB SUMMARY · Principle responsibilities a ...
-
Digital Activation
vor 1 Tag
INTERNATIONAL OLYMPIC COMMITTEE Lausanne, SchweizDepartment: Athletes' Department · Location: Lausanne, Switzerland · Contract Type: Open-ended · Activity Level: 100% · Application end date: · The International Olympic Committee (IOC) is the guardian of the Olympic Games and the leader of the Olympic Movement. A truly global o ...
-
Head of Gender Equality, Diversity and Inclusion
vor 4 Tagen
INTERNATIONAL OLYMPIC COMMITTEE Lausanne, SchweizDepartment: Corporate and Sustainable Development · Location: Lausanne, Switzerland · **Contract Type: Open Ended** · Activity Level: 100% · Start Date: · As the Head of gender Equality, Diverity and Inclusion, you will lead the development and implementation of the IOC Gender E ...
-
Université de Lausanne Lausanne, Schweiz**Introduction**: · UNIL is a leading international teaching and research institution, with over 5,000 employees and 17,000 students split between its Dorigny campus, CHUV and Epalinges. As an employer, UNIL encourages excellence, individual recognition and responsibility. · **Pr ...
-
Marketing Manager
vor 3 Tagen
Quotient Limited Eysins, Schweiz**Posted Date**:20-Jan-2023 · **Location**: Eysins, VD, CH, 1262 · **Company**:Quotient · Building on 30 years of experience in diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. Quotien ...
-
Director, Clinical Operations
vor 3 Tagen
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 ...
-
Director Pipeline Growth
vor 2 Tagen
Merck KGaA Darmstadt Germany Eysins, SchweizWork Your Magic with us · Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electron ...
-
Program Coordinator
vor 2 Tagen
IMD Lausanne, SchweizContract Type: Open-ended- Location: Lausanne, CH**About IMD** · Founded by business executives for business executives, the International Institute for Management Development (IMD) is an independent academic institute with campuses in Lausanne and Singapore as well as a Manageme ...
-
Manager, Government and National Anti-doping
vor 15 Stunden
World Anti-Doping Agency Lausanne, Schweiz**_Voir la version française à la suite de la version en anglais_** · **Manager, Government and National Anti-doping Organization (NADO) Relations** · **Group**: European Office · **Reports to**: Director, European Office and Sport Movement Relations · **Location**: WADA European ...
-
Formulation & Process Development Manager
vor 3 Tagen
Nestle Operational Services Worldwide SA Lausanne, Schweiz**Position Snapshot** · Location: Nestlé Health Science Lausanne, Switzerland or East Coast, USA · Company: Nestlé Health Science International · Act. Rate: Full-Time Act. Rate 100% · Type of contract: Permanent contract · **What we offer at Nestlé** · Flexible work policies in t ...
-
Associate Marketing Manager
vor 3 Tagen
Helen of Troy Lausanne, SchweizWe have an immediate temporary (6 months) opening for our EMEA (Europe Middle East & Africa) Headquarters in Bussigny, Switzerland for a: · Associate Marketing Manager, Wellness · Look around your home, and you'll find us everywhere: · In your kitchen, living room, bedroom, bathr ...
Regulatory Affairs Lead - Aubonne, Schweiz - Intuitive
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 Regulatory Affairs Lead plays an important role in directing the regulatory team's efforts, focusing on New Product Development (NPD) and sustaining activities within designated Business Units. This role demands a deep understanding of regulatory compliance frameworks and strategic direction within the EU. The Regulatory Affairs Lead is responsible for ensuring the alignment of regulatory strategies with company objectives, leading to successful product launches and changes. The Regulatory Affairs Lead is central to fostering an environment of excellence and innovation, guiding the team through the regulatory landscape, and ensuring that products meet stringent regulatory standards.
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.
