Network Partners is looking for a “best in class”’ Regulatory Affairs Manager to join our team. We are a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting and staffing that allows packaging engineers to work at a company dedicated to the discipline of RA while simultaneously working for some of the world’s largest and well-known medical device and pharmaceutical companies. It’s the best of both worlds. If you enjoy wildly competitive pay, a full and recently expanded benefits package and the opportunity to work with the best in the industry, then read on.
About this role:
This role could potentially be located in the NJ/NY area or in Switzerland.
The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US, CAN and AUS.
This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation.
He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities.
It also includes constant development/ improvement of product development and RA processes.
The RA manager will support international product registration by consulting the responsible RA manager for international projects.
He/she will monitor the legislative environment in main markets, i.e. EU, US, CAN and AUS and define and maintain an overview of the regulatory requirements and changes in the areas if applicable.
In addition -
Assess, approve and release communication material (IFU, leaflets, brochures).
Train and assist other departments to ensure continued compliance and timely market release.