Senior Regulatory Affairs Consultant

Locations: Switzerland (optional in Germany, Slovakia, Singapore, USA)

Contract: Permanent

Company and job overview

ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our clients appreciate our unique skill sets, pragmatic approach, and the will to win.

We are seeking an experienced Regulatory Affairs Consultant with in-depth knowledge of FDA processes for medical device and drug approval. This role will offer expert guidance on regulatory strategies, help develop effective plans for timely submission and approval, and advise on the entire regulatory process required for market entry.

Responsibilities:

• 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, incorporating Artificial Intelligence (AI), focusing on data management, AI-specific risk management, and 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 in regulatory guidelines, standards, and policies, interpreting their implications for client projects.
• Provide training to clients‘ internal teams on FDA regulations, guidelines, and processes.

Your profile

• 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.

Why Arcondis

• Become part of a global consulting company with a start-up mindset.
• Opportunity for continuous growth, improvement, and challenges.
• Opportunity for building your own team as the capability or service owner for regulatory affairs.
• Self-organizing and flat hierarchy.
• Participation in shaping Arcondis’ culture and in building the team/community.
• Flexible workplace and travel.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting and Quality Assurance

Industries

• Business Consulting and Services, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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