- 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 Sponsors 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.
- Bachelors degree in healthcare or other scientific discipline or educational equivalent.
- 5-10 years of IVD Regulatory Affairs experience with Clinical Trial Management as a plus.
- 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.
- Understanding of U.S. Food and Drug Administration (FDA) laws, regulations 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 Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint.
- Strong written and verbal communication skills including good command of English language.
- Excellent organizational, time management, and problem-solving skills.
- Attention to detail and accuracy in work.
- Ability to manage competing priorities without compromising quality.
- Effective mentoring and training skills with the ability to establish and maintain effective collaborative relationships with coworkers, managers and clients.
- Attending OneMDC (twice annual company retreat)
- Attending off-site client meetings
- Attending FDA Meetings (i.e: Pre-Submission Meeting, Submission Issue Meetings, etc.)
- Attending industry conferences (e.g. ADLM, AMDM, RAPs, etc.)
- Salary + Bonus
- Equity Plan
- Medical, Dental, and Vision Insurance
- Flexible Spending / Dependent Care Accounts
- STD/LTD/GTL/VTL
- 401(k) w/ match potential
- Generous PTO / Sick time policy
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Regulatory Affairs Consultant - Beverly, United States - MDC Associates LLC
3 weeks ago
Description
As a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. You will be responsible for the overall planning of regulatory activities and in addition provide input on clinical study design and reports for our CRO services team. You will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.
Responsibilities
Qualifications
About MDC
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. 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
By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.
Travel Requirements
10-15% Travel including local, within U.S and outside of the US. Travel may include:
Pay & Benefits:
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