The Regulatory Affairs Specialist will provide regulatory guidance to study sponsors and IVD medical device manufacturers. You will be responsible for the overall planning and direction of clinical regulatory activities. You will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.
About MDC Associates
For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world, every year. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.
By joining MDC you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and where we know our success is directly tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.
- New Client/Sponsor on-boarding including attending client conferences, defining project scope and development of project proposals.
- Development of U.S. Food and Drug Administration (FDA) Pre-Submission, Informational Meeting or Determination Meeting Submissions.
- 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 Project Managers.
- Assist clients in identifying and contracting with potential Clinical Trial Sites and/or Reference Laboratories in conjunction with assigned Project Managers.
- Assist with Institutional Review Board (IRB) submissions in conjunction with assigned Project Managers.
- 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 Sponsors throughout the submission and review processes.
- 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.
- 5-10 years Clinical Trial Management and/or Regulatory Affair Activities.
- Bachelor’s degree in a health care or other scientific discipline or educational equivalent.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines.
- Understanding of U.S. Food and Drug Administration (FDA) laws and guidances.
- Understanding of Health Canada Licensing Requirements and the EU IVDR.
- Understanding of IRB guidelines and Common Rule.
- Knowledge of applicable protocol requirements as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel, Access, Outlook and PowerPoint.
- Strong written and verbal communication skills including good command of English language.
- Excellent organizational and problem-solving skills.
- Effective time management skills.
- Attention to detail and accuracy in work.
- Ability to manage competing priorities without compromising quality.
- Effective mentoring and training skills.
- Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients.
25% Travel including local, within U.S and outside of the US. Travel may include:
- Attending off-site client meetings
- Attending FDA Meetings (i.e: Pre-Submission Meeting, Determination Meeting, Submission Issue Meetings, etc.)
- Attending annual industry conferences (i.e: Clinical Virology Symposium, American Association for Clinical Chemistry, American Society for Microbiology)
Manager, Regulatory and Clinical Affairs
Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the NorthShore (both Newburyport and Rockport lines).
Pay and Benefits
MDC Associates, Inc, offers competitive salary and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone the opportunity and structure to learn and grow.