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.
Who we are looking for:
Our ideal candidate will have 5 years medical device regulatory affairs work experience plus experience with:
- Development and execution of regulatory strategies for assigned development projects on implant systems
- Support of product development in cross functional teams
- Creation, review and/or approval of documents of the design control process
- Accountability for regulatory compliance
- Supporting international product registration
- Assessment, approval and regulatory implementation of change requests
- Review and approval of product related labeling and marketing material
- Development, review and release of all documents required for technical files
- Experience in preparation for notified body audits and FDA inspections
They should also have:
- Understanding of regulatory requirements, applicability and implementation in practice
- Understanding of product development process and principles of design control
- Understanding of quality system requirements
- Good Knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
- Good knowledge of product development processes in MD industry
- Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
- Excellent writing and communication skills as well as experience in managing cross functional projects and teams