The Project Manager for Regulatory and Clinical Affairs will plan and coordinate all activities for regulatory and clinical affairs projects while helping to facilitate the project logistics associated with submissions to regulatory authorities, including the US-FDA, EU-IVDR, Health Canada, and others.
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. 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.
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.
- Prepare and utilize project tracking tools to maintain timelines
- Monitor project progress on an ongoing basis and provide summaries and feedback to the Project Lead and client
- Attend and take minutes for regularly scheduled teleconference meetings with clients and track progress and deliverables both internally and externally
- Provide project-related support, including organization of documents, communications, and schedules, throughout the project lifecycle
- Coordinate with Clinical Affairs staff to ensure studies are properly planned and executed, including selection of study sites, development of protocols and forms, and development of databases
- Assist with the development of 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, EU Technical Files, etc.
- Bachelor’s degree in a health care or other scientific discipline or educational equivalent
- Two or more years in the medical devices industry with specific experience in in vitro diagnostic devices a plus, preferably in a Regulatory Affairs, Clinical Affairs, or Quality Systems role
- Certified Associate Project Manager (CAPM), PMP Certificate or similar certification a plus but not required
Required Knowledge, Skills and Abilities
- Excellent organizational and problem-solving skills
- Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint
- General understanding of U.S. Food and Drug Administration (FDA) laws and guidance
- General understanding of IRB guidelines and Common Rule
- Strong written and verbal communication skills including good command of English language
- Effective time management skills
- Attention to detail and accuracy in work
- Ability to manage competing priorities without compromising quality
- Comfortable speaking in front of groups of people
- Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients
Approximately 10-15% travel expected, within U.S and outside of the US.
Travel may include attending off-site client meetings, attending clinical site Initiation and Monitoring Visits, attending meetings with regulatory agencies, as well as attending annual industry conferences.
Beverly, Massachusetts OR Remote
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 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.