I am partnering with a leading Medical Device organization in Somerville, NJ to secure a Regulatory Affairs Project Manager on a 2 Year Contract to act as the facility upgrade lead and provide CMC support of day-to-day Regulatory Affairs operations.
This pays $50-$55 an hour, including expenses so this is best suited to local candidates.
- Manage activities with colleagues, and contingent workers for facility expansion and for the post approval CMC change management of the licensed biologics and 510(k) products for product life cycle.
- Work independently and serve as the point of accountability for CMC project level and product Regulatory strategies and surveillance across the full product lifecycle.
- Responsible for drafting and compiling the content and coordination of submissions, supplements and surveillance submissions while managing colleague and contingent employees to the deliverables set by the Project.
- Provide directional and creative solutions in compliance with the parameters of the requirements for Biological License Applications and CBER 510(k) products.
- Defines, develops and communicates strategy for assuring projects in work plan deliver the strategic objectives. Facility upgrade strategies can encompass multi-year (2 year +) activity.
- Lead complex regulatory negotiations for collaborative site operations.
- Establishes submission-critical components, and manages the delivery of the submission.
- Work with Project Leads to undertake specific upgrade activity as appropriate to the project. This might include: participating in productions that use the technology, assisting in building strategy for presentations and/or meeting with companies externally.
- Communicates complex concepts and influences diverse groups of stakeholders across and create an environment that is receptive and enables the upgrade of specific technologies
- Captures and monitors the impact of government regulations and other stakeholders.
- Deliver submissions, pre-submission, prior approval inspections readiness and post commitments.
- 5-8 years of experience in Regulatory Affairs in Medical Device, IVD and/or Biologics
- Experienced in CMC (Chemistry, Manufacturing Controls) filings/submissions for Biological License Applications and CBER 510(k) products
If this aligns with your experience and interests, apply now!
Sthree US is acting as an Employment Business in relation to this vacancy.