You have an opportunity to play a crucial role in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients. At MDC Associates, that’s our mission, and we need you to help us meet the growing demand for better clinical tools.
As a Project Manager for Regulatory and Clinical Affairs, you will plan and coordinate activities for Regulatory and Clinical Affairs projects and logistics associated with submissions to regulatory authorities, including the US-FDA, EU-IVDR, Health Canada, and others.
- Plan and coordinate activities for Regulatory and Clinical Affairs projects and logistics
- Implement and utilize tools to track and achieve project deadlines
- Report on progress across all projects at a department, executive, and client level
- Attend and record minutes for client and team meetings
- Provide project-related support, including record management, communications, schedules, and data throughout project lifecycles
- Coordinate clinical study planning and execution with Clinical Affairs, including site selection, documents and templates, and development of protocols and databases
- Assist with U.S. Food and Drug Administration (FDA) Pre-Submission communications
- Assist with the compilation, review, and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, E.U. Technical Files, etc.
- Bachelor’s degree in a health care or other scientific discipline or educational equivalent
- 2+ years of project management experience (experience in the medical devices industry preferred
- Certified Associate Project Manager (CAPM), PMP Certificate, or similar certification preferred, not required
- Experience managing and delivering initiatives that involve multiple cross-functional teams
- Ability to manage competing priorities and drive initiatives without compromising quality
- Ability to communicate information from complex sources and present options/solutions to multiple stakeholders and diverse teams
- Excellent organizational, problem-solving, and time management skills
- Proficiency across the Microsoft Office Suite
- Attention to detail and accuracy in work
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 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 know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.
MDC Associates, Inc. is an Equal Opportunity Employer committed to a diverse workforce. MDC Associates, Inc. will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.
10-15% Travel including local, within the U.S and outside of the U.S. Travel may include:
- Meetings with clients, study sites and regulatory agencies
- Attending scientific, medical, and industry conferences
Regulatory and Clinical Affairs Manager
In-Office: Beverly, Massachusetts with some remote work
Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).
Pay and Benefits
MDC Associates, Inc, offers competitive salaries 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.