Overview:
We are seeking an experienced Regulatory Affairs Manager to spearhead regulatory initiatives within our In Vitro Diagnostics (IVD) consultancy located in Acton, MA. This role involves leading regulatory strategies, ensuring compliance, and providing expert guidance to clients in the IVD industry, with a three-day hybrid work model.
Responsibilities:
Lead and manage regulatory strategies and submissions for IVD products, ensuring alignment with global regulations (FDA, EMA, etc.) and client-specific needs.
Offer expert guidance and support to clients, facilitating the preparation and review of regulatory documents (510(k), PMA, CE Marking, etc.) and submissions.
Develop and maintain strong relationships with regulatory agencies, staying updated with evolving regulations, and implementing necessary changes to ensure compliance.
Lead a team of regulatory professionals, providing mentorship, direction, and fostering a culture of excellence and collaboration.
Collaborate cross-functionally with internal teams and clients to integrate regulatory considerations into product development and market entry strategies.
Requirements:
Bachelor’s degree in a scientific discipline, life sciences, or related field (advanced degree preferred).
2+ years of progressive experience in regulatory affairs within the IVD industry, particularly in a consultancy role.
Demonstrated success in leading regulatory strategies and submissions for IVD products.
In-depth knowledge of global regulatory requirements and guidelines specific to IVD devices.
Strong leadership, decision-making, and problem-solving skills.
Excellent communication, negotiation, and interpersonal abilities.
Benefits:
Competitive compensation package.
Opportunity to lead regulatory initiatives in a dynamic consultancy environment focused on IVD in Acton, MA.
Three-day hybrid work arrangement, offering flexibility and work-life balance.
Collaborative and innovative work culture.
Health and wellness programs.
Potential for professional growth within the organization.