Outstanding opportunity to be a part of a forward thinking regulatory affairs organization. The Senior Specialist, regulatory Affairs will focus on supporting sustaining engineering for our critical care monitoring products. This opportunity presents a unique challenge in refreshing our submissions. We are looking for a diligent Sr. RA professional who works well across functional teams, takes initiative, and enjoys working in a fast paced team environment. Job Description:
- Represent regulatory affairs on sustaining engineering, product development and commercialization teams related to Critical Care Monitoring Products.
- Interacts with FDA and other regulatory bodies for submissions and projects.
- Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
- Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
- Able to collaborate and take direction from team leaders, while working with RA management on resolution of RA issues and strategy.
Qualifications/Required Skills/Experience and Education:
- A minimum of five years of experience within medical device regulatory affairs is required, for the Sr. RA role.
- A Bachelor’s degree is required. A science degree is strongly preferred.
- Experience with Class II devices preferred. Relevant experience includes, experience with hemodynamic monitoring devices.
- Experience in preparing US and EU product submissions are required.
- Must be competent in applying the appropriate l regulatory requirements for new products or product changes as it relates to labeling and advertising of class II and III devices. –
- Requires familiarity with new product development systems.
- Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices.
- Must have strong written and verbal communication skills, and have experience working on cross functional project
- Strong ability to problem solve and apply analytical thinking is required.