Senior Regulatory Officer
Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch.
Phillips-Medisize A/S is launching a new offering, platform projects, as an addition to bespoke product development. Platforms are intended to reduce development effort, and time to market by creating variants based on the existing design and technical documentation of a pre-defined platform. The success of the platform scheme relies on re-use of the platform technical documentation to accommodate medical devices with a similar intended use, user profile, use case scenario, regulatory approval pathway, and claims.
We are looking for an experienced and self-driven RA Senior manager/specialist who is able to support this ambition.
What You Will Do In Your Role
- Transform insights and experience with global regulatory approval into a smart and widely accepted solutions for the company and its clients;
- Cooperate closely with the platform owners and the commercial team to understand the market needs and offerings on a global scale;
- Be the main driver of defining, developing, and maintaining the regulatory approval strategy for the variant, in cooperation with the existing regulatory affairs team;
- Support the commercial team when discussing platform-related projects with potential clients by ensuring sufficient information are collected, answering regulatory questions and assessing potential to be part of the platform scheme;
- Coordinate, develop, and drive the approval and registration process, worldwide, with the support of the existing regulatory affairs team;
- Support maintenance activities for marketed variants to ensure compliance and validity of the approval/registration at all time;
- Document, improve, enhance, and maintain the platform development process (process, procedure, and templates;
- Spread awareness and knowledge throughout the organization on the platform process, the advantages, the limitations, and the regulatory approval process to ensure compliance and maximize benefits;
- Collect and report any gaps, potential for improvement, needed infrastructure and knowledge.
The Experience You Will Bring
- High level of regulatory expertise related to medical devices (preferably previous experience in pharma sector is valued);
- Experience and ability to work on strategic level, globally and across disciplines;
- Result Oriented - Ability to make lean plans and to transform them into actionable items to enable meeting the company objectives and customer expectations;
- Structured, dynamic, and self-driven;
- Outspoken and able to win clients and internal stakeholders trust and approval.
What Will Put You Ahead
- Knowledge in configuration management
- Experience with platform projects
- Expertise in global product registration/approval