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Natalie Muth
Natalie Muth
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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.   

Project Services

 

Senior Regulatory Affairs Consultant

- Develop and implement regulatory affairs services and related capabilities according to current and future market needs and trends 

- Support business development on regulatory affairs related services 

- Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their medical devices and pharmaceutical products to market. 

- Consult with clients on the clinical data necessary to support device and drug approval.  

- Consult with clients in implementation of additional components beyond the standard ISO 13485, that incorporates Artificial Intelligence (AI), i.e. focus on data management, AI-specific risk management, ethical considerations  

- Prepare, review, and submit high-quality regulatory submissions for global registration, including 510(k) Notices, PMA applications, De Novo requests, IND applications, and NDA submissions. 

- Serve as the main liaison between clients and regulatory authorities, facilitating effective communication and swift resolution of issues. 

- Support clients in the post-market surveillance and reporting process, including guidance on MDRs, recalls, inspections, and adverse event reporting for pharmaceutical products. 

- Keep abreast of changes regulatory guidelines, standards, and policies, interpreting their implications for client projects. 

- Provide training to clients' internal teams on FDA regulations, guidelines, and processes.

1

- Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field. 

- Minimum of five years' experience in Regulatory Affairs within the medical device and pharmaceutical industries, with a strong focus on FDA processes. 

- In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products. 

- Demonstrated success in managing submissions and gaining device and drug approvals. 

- Excellent written and verbal communication skills. 

- Leadership skills and the ability to form effective teams for project delivery 

- Proficiency in project management and ability to handle multiple projects simultaneously. 

- Deep understanding of Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and Good Clinical Practices (GCP). 

- Willingness to travel 

- Professional certification in Regulatory Affairs (RAC) is preferred. 

- Experience with Class II and Class III medical devices and ATMPs preferred. 

- Experience with SaMD, including AI incorporation is preferred 

- Previous consulting experience is preferred. 

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Basel, Frankfurt, Kosice, Singapore, Boston

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