20 beste Stellen als technical lead in lausanne, vd – aktuell auf Personalsuche

Regulatory Affairs Expert
Tandem Diabetes Care —Lausanne, VD
- 100%
- Schreibfähigkeiten
- Englisch
- Bachelor
Direkt bewerben
13 Tage
Product Manager - Platform Engineering
Frontiers Media —Lausanne, VD
- 100%
- Hybrides Arbeiten
- Englisch
- Führungserfahrung
- Verhandlungsgeschick
Direkt bewerben
1 Tag
Internship - Development Automation Workflows on a Robotic Platform for Purification process (m/f/d)
Merck KGaA —Corsier-sur-Vevey, VD
- Forschungserfahrung
- Master
- Praktikum
- Aufstiegsmöglichkeiten
Aerodynamics Design Engineer
Harmattan AI —Lausanne, VD
- 100%
- Doktorat
- Master
- Bachelor
Senior System Engineer
ELCA Informatique SA —Pully, VD
- 100%
- Englisch
- Windows
- Master
2 Tage
Sales Engineer, French Fluency Required (80–100%)
ABB —Morges, VD
- 100%
- Vertrieb
- Bachelor
- Kommunikationsfähigkeit
Internship - Microbiology Quality Control (m/f/d)
Merck KGaA —Corsier-sur-Vevey, VD
- Englisch
- Praktikum
- Aufstiegsmöglichkeiten
6 Tage
Technical Account Manager
Neural Concept —Paris (75)
- 100%
- Englisch
QA QMS Senior Specialist
Ferring Pharmaceuticals, Inc. —Saint-Prex, VD
- 100%
- Management-Erfahrung
- Englisch
- Master
- Eltern-/Erziehungsurlaub
1 Tag
Aerodynamics Testing Engineer
Harmattan AI —Lausanne, VD
- 100%
- Master
- Datenbanken
- Bachelor
Head of Product, Cloud
Pix4D —Lausanne, VD
- 100%
- Hybrides Arbeiten
- Microsoft Excel
- Englisch
- Master
Direkt bewerben
14 Tage
LLM Architect
Giotto.ai —Lausanne, VD
- 100%
- Homeoffice
- Doktorat
- Forschungserfahrung
- Master
Direkt bewerben
Internship - Data Scientist - AI Solutions for Manufacturing (m/f/d)
Merck KGaA —Aubonne, VD
- Analysefähigkeit
- Softwareentwicklung
- Praktikum
- Aufstiegsmöglichkeiten
Medical Director, Oncology
Debiopharm —Lausanne, VD
- 100%
Software Engineer, iOS Core Product - Lausanne, Switzerland
Speechify —Lausanne, VD
- Homeoffice
- Doktorat
- Kommunikationsfähigkeit
Senior Product Manager - Logitech Video Solutions
Logitech —Lausanne, VD
- 100%
- Englisch
- Master
- Analysefähigkeit
- Homeoffice-Möglichkeit
Project Scheduler/Steerer (CDM 18 months) - All Genders
Merck KGaA —Aubonne, VD
- Zweisprachig
- Englisch
- Master
- Aufstiegsmöglichkeiten
P2612 - Senior Manager Statistical Programming
Debiopharm —Lausanne, VD
- 100%
- Informatik
- Master
- Softwareentwicklung
Direkt bewerben
(Senior) Product Manager, Endpoint
Nexthink —Lausanne, VD
- 100%
- Hybrides Arbeiten
- Informatik
- Management-Erfahrung
- Englisch
Direkt bewerben
Cleaning Validation Expert (m/f/d)
Merck KGaA —Aubonne, VD
- 100%
- Schreibfähigkeiten
- Englisch
- Master
- Aufstiegsmöglichkeiten

Ich möchte aktuelle Job-E-Mails für Stellen als technical lead in lausanne, vd erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

technical lead jobs near lausanne, vd

Jobs als Software Engineer in Lausanne, VD

Jobs als Platform Engineer in Lausanne, VD

Jobs als Regulatory Affairs Specialist in Lausanne, VD

Jobs als Architect in Lausanne, VD

Jobs als Test Engineer in Lausanne, VD

Jobs als Head Of Product in Lausanne, VD

Jobs als Sales Engineer in Basel, Bs

Jobs als Sales Engineer in Lausanne, Vd

Jobs als Sales Engineer in Bern, Be

Jobs als Sales Engineer in Genève, Ge

Jobs als Praktikum Junior Cisco Network Engineer, Switzerland, 70k 80k Chf in Baden, Ag

Jobs als Software Engineer in Zürich, Zh

Jobs als Software Engineer in Kanton Zug

Jobs als Software Engineer in Home Office

Jobs als Pre Sales Engineer in Zürich, Zh

Jobs als Platform Engineer in Bern, Be

Jobs als Platform Engineer in Zürich, Zh

Jobs als Platform Engineer in Bâle, Bs

Jobs als Senior Development Engineer in Zürich, Zh

Jobs als Platform Engineer in Baar, Zg

Regulatory Affairs Expert

Tandem Diabetes Care -
Lausanne, VD

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 13 Tagen

Qualifikationen

Französisch
Schreibfähigkeiten
Englisch
Bachelor

Vollständige Stellenbeschreibung

Job Description

GENERAL SUMMARY:

The Regulatory Affairs Expert is responsible for developing and executing strategies to support products registrations, entity set-up and ongoing compliance with country-specific requirements. Acting as the local subject matter expert, the role ensures adherence to applicable regulations, including support to economic operator obligations, and may support both locally marketed products and regulatory activities for global portfolios, through submission , licenses maintenance and regulatory body interactions. The position also drives local regulatory intelligence activities, translates evolving requirements into actionable guidance for the business, and ensures compliance with applicable quality systems and regulations, including 21 CFR Part 820, EU 2017/745 (MDR), UK MDR 2002, ISO 13485, and local frameworks.

PRIMARY DUTIES & RESPONSIBILITIES:

Defines and implement international regulatory strategies to support product registrations, lifecycle management and expansion in assigned markets
Execute new products submissions and post-approval change management activities in compliance with applicable regulatory requirements.
Ensure in country regulatory readiness for product launches in alignment with business timelines
Lead registration, maintenance and compliance of local legal entities and support economic operators obligations, ensuring alignment with applicable regulations and company strategies.
Monitor and proactively manages the status of regulatory activities, ensuring timely escalation of risks and alignment with business timelines.
Acts as the primary RA contact with local Authorities, regulatory partners as applicable.
Respond to customer queries and support the RA portion of tender applications
Represents International RA in cross-functional teams, ensuring alignment with quality, commercial, supply chain and any other stakeholder as applicable
Interprets international regulations and provides clear guidance on their impact on local entities, local practices, commercialization and lifecycle management.
Conducts Regulatory Intelligence and contributes to regulatory advocacy for the defined markets
Identifies regulatory risks and gaps in plannings and propose appropriate mitigation and strategic solutions.
Ensures compliance with quality management system and company policies, including legal and regulatory requirements.
Acts as Tandem representative in internal and external regulatory audits and inspections as needed.
Ensures continuous exchanges with Tandem corporate to align on regulatory strategy.
Reviews and analyzes project and customer requirements and assists project teams in tailoring and using regulatory procedures, methods, templates and tools.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Ensures accurate documentation and tracking of regulatory activities, submissions and licenses in internal systems.
Develops, maintains and continuously improves internal regulatory processes and procedures.
May contribute to health economic dossier preparation
Other responsibilities as assigned.

REQUIRED QUALIFICATIONS:

Knowledge, skills & abilities:

Proficient knowledge of regulatory and quality standards: MDR 2017/745, ISO 13485, MDSAP, ISO 14971and other appropriate laws, guidelines and industry standards.
Knowledge of 21 CFR Part 820 is a plus
Demonstrated experience communicating with regulatory bodies such as EU, international regulatory agencies and notified bodies.
Understanding of strategic and tactical role of Global Regulatory Strategy in the product development and commercialization process.
Ability to analyze, interpret translate and simplify technical content or regulations and communicate to stakeholders.
Skilled at creating a cooperative team environment.
A positive approach to people and problem solutions.
Fluent in French and English (C1 proficiency minimum).

Minimum certifications/educational level:

Bachelor's degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or equivalent combination of education and applicable job experience.
Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.

Minimum experience:

10 plus years of related experience in regulatory function in medical device industry.
Demonstrated experience in leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions, (e.g., 510(k), De Novo, CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).

JOB SCOPE

Having wide-ranging experience and resolves complex issues in creative and effective ways.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Determines methods and procedures on new assignments and may coordinate activities of other personnel.

Direkt bewerben

Erweiterte Suche

technical lead Jobs in lausanne, vd

Regulatory Affairs Expert

Product Manager - Platform Engineering

Internship - Development Automation Workflows on a Robotic Platform for Purification process (m/f/d)

Aerodynamics Design Engineer

Senior System Engineer

Sales Engineer, French Fluency Required (80–100%)

Internship - Microbiology Quality Control (m/f/d)

Technical Account Manager

QA QMS Senior Specialist

Aerodynamics Testing Engineer

Head of Product, Cloud

LLM Architect

Internship - Data Scientist - AI Solutions for Manufacturing (m/f/d)

Medical Director, Oncology

Software Engineer, iOS Core Product - Lausanne, Switzerland

Senior Product Manager - Logitech Video Solutions

Project Scheduler/Steerer (CDM 18 months) - All Genders

P2612 - Senior Manager Statistical Programming

(Senior) Product Manager, Endpoint

Cleaning Validation Expert (m/f/d)

Ich möchte aktuelle Job-E-Mails für Stellen als technical lead in lausanne, vd erhalten

Related Searches

Weitere Job-Standorte erkunden

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt