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Regulatory Affairs Specialist

2 months ago

Beverly, Massachusetts, United States MDC Associates Full time
Job Overview

As a Regulatory Affairs Consultant, you will spearhead regulatory initiatives and offer expert guidance to manufacturers of in vitro diagnostic (IVD) devices. Your role will encompass the comprehensive planning of regulatory activities, along with providing insights on clinical study design and documentation for our Clinical Research Organization (CRO) services team. You will formulate and execute strategies in a collaborative setting with colleagues and clients, aiming for successful regulatory submissions.

Key Responsibilities

  • Delivering regulatory advice and formulating strategies to support client and sponsor regulatory and market goals.
  • Creating FDA Q-subs in partnership with clients, including Pre-subs, Breakthrough, and STeP submissions.
  • Contributing to the content of submission documents based on regulatory experience and guidelines from relevant authorities.
  • Assisting in the development of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Databases, and Data Collection Forms in collaboration with Clinical Affairs Scientists and Project Managers.
  • Supporting clients throughout the product development lifecycle as required.
  • Overseeing the development, compilation, review, and submission of regulatory filings such as FDA 510(k), de novo, PMA submissions, Health Canada Licensure, and EU Technical Files.
  • Engaging with regulatory agencies and sponsors during the submission and review phases.
  • Contributing to business development efforts, early client engagement, defining project scopes, and assisting in the creation of project proposals.
  • Implementing regulatory processes in accordance with company protocols, clinical studies, testing, and documentation, ensuring alignment with company policies.

Qualifications

  • Bachelor's degree in a healthcare or scientific discipline or equivalent educational background.
  • 5-10 years of experience in IVD Regulatory Affairs, with a focus on Clinical Trial Management being advantageous.
  • Thorough understanding of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines.
  • Familiarity with U.S. Food and Drug Administration (FDA) laws, regulations, and guidance.
  • Knowledge of Health Canada Licensing Requirements and the EU IVDR, as well as IRB guidelines and the Common Rule.
  • Proficiency in relevant protocol requirements as outlined in company training.
  • Strong computer skills, including proficiency in Office 365, Microsoft Word, Excel, Access, Outlook, and PowerPoint.
  • Excellent written and verbal communication skills, with a strong command of the English language.
  • Outstanding organizational, time management, and problem-solving abilities.
  • Meticulous attention to detail and accuracy in all tasks.
  • Capability to manage multiple priorities without sacrificing quality.
  • Effective mentoring and training skills, with the ability to foster and maintain collaborative relationships with colleagues, managers, and clients.

About MDC Associates

For over three decades, MDC Associates has empowered innovators and entrepreneurs to bring in vitro diagnostics (IVD) and medical devices to market, positively impacting the lives of millions globally. Our mission is to continue supporting these innovators by leveraging our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to facilitate the launch of groundbreaking advancements that enhance and safeguard the health of our communities.

Travel Requirements

Expect 10-15% travel, which may include:

  • Participation in company retreats
  • Off-site client meetings
  • Meetings with regulatory agencies
  • Attendance at industry conferences

Compensation & Benefits:

  • Competitive salary with bonus potential
  • Equity plan
  • Comprehensive medical, dental, and vision insurance
  • Flexible spending and dependent care accounts
  • Short-term and long-term disability insurance
  • 401(k) plan with matching potential
  • Generous paid time off and sick leave policy