Regulatory Affairs Consultant - IVD/CDx

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April 3

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MDC Associates, Inc.

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Healthcare Insurance • Biotechnology • Science

MDC Associates, Inc. is a trusted partner for Contract Research Organization (CRO) services, specializing in Data Management, Regulatory Affairs, and Quality Systems in the In Vitro Diagnostics (IVD) industry. The company offers comprehensive support for clinical studies, regulatory audits, quality management, and IVD market clearance, focusing on microbiology, clinical chemistry, infectious diseases, and diagnostic technologies. MDC Associates collaborates with startups, growing businesses, and established companies, providing tailored strategies, quality system development, regulatory guidance, and global network access. With over 35 years of expertise and a strong relationship with the FDA, they guide IVD makers through market clearance processes effectively and ensure compliance with regulatory standards.

11 - 50 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🔬 Science

📋 Description

• The Regulatory Affairs Consultant is self-motivated with a proven track record of regulatory clearances. • The individual will be tasked to lead regulatory projects, provide strategic regulatory guidance to IVD and CDx clients, and expand relationships with existing clients. • Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives. • Developing FDA Q-subs in collaboration with clients (Pre-subs, Breakthrough, STeP). • Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies. • Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with assigned Clinical Affairs Scientist and Project Managers. • Assist client with product development process as needed. • Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc. • Interaction with regulatory agencies and clients throughout the submission and review processes. • Assist with business development, early client engagement, defining project scopes and supporting development of project proposals. • Implementation of regulatory processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures. • Collaborate to drive MDC's commercialization strategy to support continued growth. • Supports the promotion of MDC through tradeshow attendance, speaking engagements, and other marketing initiatives.

🎯 Requirements

• Bachelor's degree in healthcare or other scientific discipline, required • 5+ years of direct IVD regulatory experience, required • CDx experience, preferred • Quality experience, preferred • Demonstrated consensus building and project leadership skills. • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines. • Positive team-player. • Understanding of U.S. Food and Drug Administration (FDA) laws, regulations and guidance. • Understanding of Health Canada Licensing Requirements and the EU IVDR. • Understanding of IRB guidelines and Common Rule. • Excellent written, verbal, and formal presentation skills. • Demonstrated track record of successful regulatory clearances. • Strong understanding of IVD and CDx ecosystem required. • Excellent organizational, time management, and problem-solving skills. • Attention to detail and accuracy in work. • Ability to manage competing priorities without compromising quality. • Up to 20% travel.

🏖️ Benefits

• Medical, Dental, and Vision Insurance. • Health Reimbursement Account (HRA) • Flexible Spending (FSA) / Dependent Care Accounts (DCA) • Short and Long-Term Disability • Group Term Life Insurance • 401(k) with Safe Harbor Match • Unlimited PTO • 13 Paid Holidays