Senior Consultant Regulatory Affairs MedTech

vor 1 Monat

Basel, Schweiz Arcondis Vollzeit

ABOUT ARCONDIS

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.

We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.

Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.

About us

MISSION

Tasks and responsibilities

We are looking for an experienced Regulatory Affairs professional to join our dynamic international consulting team and play a key role on a project for one of our key clients.

  • Consult our clients in development and implementation of regulatory strategies, identifying the most efficient and compliant regulatory pathways to bring clients’ products to the market

  • Advise our clients on the regulatory data (e.g. EUDAMED) and information necessary to support dossier submission mainly to EU and US health authorities

  • Perform gap analysis on existing dossiers for regulatory approvals or clearance

  • Support clients in the liaison with health authorities, facilitating effective communication and swift resolution of issues

  • Consult and support our clients in implementation of additional components beyond the standard ISO 13485, that are required for a Quality Management System (QMS) that incorporates Artificial Intelligence (AI), e.g. focus on data management, AI-specific risk management, ethical considerations

  • In close collaboration with our clients support from regulatory perspective implementation and maintenance of clients’ Quality Management Systems acc. to ISO 13485

  • Keep abreast of changes in global regulatory guidelines, standards, and policies, interpreting their implications for client projects

  • Provide training to clients' internal teams on global regulations, guidelines, and processes

  • Be a driver of our business development and regulatory affairs services

STUDIES

Your profile

  • Bachelor's or Master's degree in Life Sciences, Regulatory Affairs or correlated field

  • Minimum of 10 years' experience in Regulatory Affairs within the MedTech industries

  • In-depth knowledge and understanding of EU and US MedTech regulations and submission processes

  • Experience in communication and exchange with Health Authorities for SaMD, AI, Robotics submissions, like FDA, EMA

  • Demonstrated success in preparing and managing EU and US submissions and approvals, incl. 510k

  • High degree of quality awareness

  • Strong attention to detail, self-contained, and responsible way of working

  • Good understanding of Good Manufacturing Practices (GMP)

  • Proficiency in project management and ability to handle multiple projects simultaneously

  • Excellent English written, and verbal communication skills, German and other languages are a plus

  • Ability to work in international and interdisciplinary teams

  • Willingness to continuously improve and to grow with new challenges

  • Willingness to travel, including overseas

  • Senior Manager Regulatory Affairs

    vor 3 Wochen

    Basel, Schweiz Veristat Vollzeit

    Description : Senior Manager Regulatory Affairs Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies...

  • Senior Manager Public Affairs

    vor 3 Wochen

    Basel, Schweiz Veristat Vollzeit

    Description : Senior Manager Public Affairs Would you like to join and contribute to a successful and growing multinational organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in...

  • Director Regulatory Affairs

    vor 3 Wochen

    Basel, Schweiz Veristat Vollzeit

    Description : Director Regulatory Affairs Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Basel, Schweiz LHH Vollzeit

    We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...

  • Regulatory Affairs Manager

    Vor 4 Tagen

    Basel, Schweiz CPL Recruitment Vollzeit

    **Posted date **15 April 2024 **Location**Basel **Job type** Permanent **Salary**Negotiable **Discipline** Life Sciences **Reference**JO-2404-533260 **Work Location** Hybrid An exciting and growing business looking to bring state-of-the-art medical technology to the market, enabling people globally to self-manage diabetes and other chronic diseases,...

  • Regulatory Affairs Application Support Consultant

    Vor 5 Tagen

    Basel, Schweiz Arcondis Vollzeit

    ABOUT ARCONDIS Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and...

  • Head of Regulatory Affairs, Cmc

    vor 4 Wochen

    Basel, Schweiz Barrington James Vollzeit

    Basel, Switzerland - 15-06-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - Regulatory Affairs - SALARY TYPE - Annually - SALARY - Negotiable Position: Head of Regulatory Affairs, CMC & Drug Substances **Responsibilities**: - Establishing and implementing the corporate Regulatory Affairs and CMC development standard across multiple...

  • Regulatory Affairs Scientific Leader

    Vor 5 Tagen

    Basel, Schweiz Hobson Prior Vollzeit

    **Salary**: CHF120000 - CHF130000 per annum**Job type**: Permanent **Location**: Basel, Schweiz **Function**: Regulatory Affairs, Development **Posted**:22/01/2024 **Ref**: BBBH24375 - Hi I'm Henry , I manage this role Hobson Prior are partnering with a brilliant pharmaceutical organisation who are seeking for an individual to join their team on a...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...

  • Manager, Regulatory Affairs, International

    vor 4 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Manager, Regulatory Affairs, International** One of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Basel, Schweiz ProClinical Vollzeit

    **Salary**: Highly Competitive Job type: PermanentDiscipline: Project Manager**Location**: Switzerland- Basel, Schweiz - Posting date: 27 Feb 2024 Reference: 57992 Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to...

  • Associate Director Regulatory Affairs Biosimilars

    vor 1 Monat

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...

  • Associate Director Regulatory Affairs Biosimilars

    vor 3 Wochen

    Basel, Schweiz Abbott Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...

  • Raqa (Regulatory Affairs and Quality Assurance)

    vor 1 Woche

    Basel, Schweiz Indivi Vollzeit

    **Your mission**: We are committed to transforming healthcare and clinical research by harnessing the power of Digital Biomarker technology. Specializing in the development of innovative software as medical devices, we strive to revolutionize patient outcomes and elevate the standard of healthcare delivery. As our RAQA (Regulatory Affairs and Quality...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Basel, Schweiz Pharma-Jobs24 Vollzeit

    Sie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt! bruederlinpartner bringt als spezialisierter Personaldienstleister jeden Tag Fach - und Führungskräfte mit nationalen und internationalen...

  • Associate Director, Regulatory Affairs

    Vor 4 Tagen

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1710 - Who we are - Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. -...

  • Regulatory Affairs Manager Pharma Eu/ch

    vor 1 Woche

    Basel, Schweiz Bernwald Personalberatung GmbH Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **Arbeitsort**: Grossraum Zürich Aufgaben - Selbständiges Erstellen von...

  • Associate Director, Regulatory Affairs

    vor 2 Wochen

    Basel, Schweiz Vectura Vollzeit

    Who we areVectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology, and Fertin Pharma, experts in oral and intra-oral delivery systems.We are driven by the exciting and unique goal of addressing...

  • Emerging Markets Regulatory Affairs Strategy Lead

    vor 4 Wochen

    Basel, Schweiz Abbott Laboratories Vollzeit

    **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Abbott Established Pharmaceuticals (EPD) is looking for a **EM Regulatory Affairs Strategy Lead** for its global Pharma Division Headquarter...

  • Director of Regulatory Affairs Cmc

    vor 4 Wochen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel. **Responsibilities**: - Lead the system owners through the issuance, proposal and upkeep of all regulatory documents such as DMF's, CMC documentations for INDs, IMPDs, NDAs, MAAs,...