In this role, you have the opportunity to
Support manufacturing location changes for Sleep & Respiratory Care and Hospital Respiratory Care.
You are responsible for
Coordinate and Manage Regulatory Timelines for projects / products shared across different business units
Participate in reviews of new and/or revised guidance’s, regulations and standards applicable to the business unit. Train business on new / revised guidance’s, regulations and standards.
Manage and lead special regulatory focused projects and process improvements across the business.
Process lead for new projects such as PDLM, PQMS, etc.
Provide Regulatory Affairs Support for New Product Development, Sustaining, and Advanced Development efforts in both the domestic and international markets for assigned business unit. Provide direct project support for registration and licensing in mature markets and indirect support to the Emerging Markets group for all other licensing, as deemed necessary.
Lead and manage International Registration projects for complex countries (ex. Japan, Brazil, China) and interface between Business Marketing / Regulatory and In- Country Marketing / Regulatory
Mentors Regulatory team members
To succeed in this role, you should have the following skills and experience
B.S. or equivalent in Engineering, Life sciences, or other similar technical field. Master’s degree preferred. RAC preferred. Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position.
Project Management experience. PMP preferred.
Experience in creating and executing Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
Experience in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD and/or MDR), CA (Health Canada), and AU (TGA).
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others.
Minimum 5 years of experience in the medical device industry
Experience in supporting international registrations
KP RECRUITING GROUP
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.
In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.
See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General