Senior Consultant Regulatory Affairs MedTech (SaMD, AI, Robotics)

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About us

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.

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

- 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

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