Regulatory Affairs Fda Consultant

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 digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love working with us because of 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 to our clients on regulatory strategies, help develop effective plans for timely submission and approval, and advise on the entire regulatory process required for market entry.

Responsibilities

• Keep abreast of changes in FDA regulatory guidelines, standards, and policies, interpreting their implications for client projects.
• Provide training to clients' internal teams on FDA regulations, guidelines, and processes.
• Prepare, review, and submit high-quality regulatory submissions to the FDA, including 510(k) Notices, PMA applications, De Novo requests, IND applications, and NDA submissions.
• Support clients in the post-market surveillance and reporting process, including guidance on MDRs, recalls, inspections, and adverse event reporting for pharmaceutical products.
• Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their medical devices and pharmaceutical products to market.
• Serve as the main liaison between clients and FDA, facilitating effective communication and swift resolution of issues.
• Active support in the business development
• Advise clients on the clinical data necessary to support device and drug approval, including the design and review of clinical studies.

Qualifications and Experience

• Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field.
• Deep understanding of Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and Good Clinical Practices (GCP).
• Excellent written and verbal communication skills.
• Demonstrated success in managing FDA submissions and gaining device and drug approvals.
• Proficiency in project management and ability to handle multiple projects simultaneously.
• Willingness to travel to the West Coast.
• In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.
• Minimum of five years' experience in Regulatory Affairs within the medical device and pharmaceutical industries, with a strong focus on FDA processes.

Benefits

• Opportunity for continuous growth, improvement, and challenges
• Self-organizing and flat hierarchy
• Participation in shaping Arcondis’ culture and in building the team/community
• Becoming part of a global consulting company with a start-up mindset