Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
As the Regulatory Affairs Specialist, you will be responsible for maintaining product registrations for our medical devices and helping to ensure regulatory compliance of Mermaid Medical devices throughout their entire product lifecycles. You will support the organization by providing regulatory advice and helping formulate and implement regulatory strategies across multiple projects while working with various departments across the organization such as Marketing, Clinical, R&D, and Quality Assurance.
This job position is based out of the office located in Sarasota, FL allowing you to work efficiently with colleagues located both in the US and at the headquarter office located near Copenhagen, Denmark. Occasional international travel can be expected as you will be working daily with a global team.
As the Regulatory Affairs Specialist, you will report to the Regulatory Manager, and you will be responsible for regulatory tasks as described below.
Main responsibilities
You will be working in different highly skilled international teams.
Your skillset
The successful candidate has a great sense of responsibility, reliability with high-quality standards, and is committed to meeting deadlines.
What Do You Get?
We offer the following benefits package to full-time employees:
We also offer local relocation within the state of Florida.
You will be part of an organization where we value teamwork and where we look out for each other. We are of the strong belief that no one can accomplish everything on their own, and therefore we value and utilize each other’s strengths. We care about and foster an environment where you can always find a helping hand across functions and borders.
The Application Process
Apply to be our new Regulatory Affairs Specialist by uploading a cover letter and your current curriculum vitae using the link on this site. We only receive applications through our recruitment systems.
The applications will be reviewed on an ongoing basis.
We look forward to receiving your application.
About Mermaid Medical Group:
Mermaid Medical Group is a privately owned company established in 2007. With our Nordic roots and headquarters in Denmark, we value cooperation, helpfulness, and openness. We develop, manufacture, and distribute medical devices to hospitals and end-users across Europe, the U.S., and Asia. We primarily work within solutions to diseases in the vascular system as well as other devices used in interventional radiology. We strive to be the preferred partner for manufacturers as well as hospitals and health care professionals so that together we can help even more patients.
Being One of Us:
We believe that as people, and as a company, We Are One. We have a culture of sticking together and doing what is best for each other and the company. We are proud of our life-saving products, and we trust that each and every one of our colleagues do their best to ensure happiness and quality of life, both for the patients who benefit from our products as well as for each other.
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