Regulatory Affairs Specialist in an international medical device company

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

• Support maintenance of EU, US, Canadian, etc. registrations and listings for Class II/III medical devices
• Support the organization with regulatory advice
• Updating databases (EUDAMED/GUDID/etc.) and creating/maintaining required documentation
• Contributing to the medical device intelligence review and monitoring
• Coordination of post-market surveillance activities
• Assist with the submission and management of recalls/FSN’s and adverse event/incident reports
• Responsible for assisting in pre-market submissions, license applications, and product registrations for medical devices in target countries
• Provide regulatory support in new product development projects
• Supporting the Regulatory Manager communicating with responsible regulatory authorities (national/international) as well as with notified bodies by maintaining current knowledge of the developments and changes to applicable laws, regulations, and industry standards
• Creating and maintaining Technical File documentation and submission documentation in compliance with the relevant regulatory requirements
• Participate in corrective and preventive action (CAPA) activities
• Support and participate in audits (internal/external)
• Maintaining the regulatory processes within the Quality Management System
• Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
• Implementing the UDI and labeling requirements together with our R&D and QA team
• Works cooperatively with R&D, process development, quality, manufacturing, clinical, and marketing on complex projects to ensure success

You will be working in different highly skilled international teams.

Your skillset

• Minimum 1-3 years of experience in a quality or regulatory role, preferably within the medical device industry
• Knowledge and experience of the relevant regulations preferred, i.e., MDR, FDA, relevant laws, and guidelines, such as MEDDEV, applicable standards, etc.
• Engineer or bachelor’s degree in science or a related field and/or medical device experience
• Team player
• Fluent English, written and spoken
• Ability to perform detailed tasks with accuracy
• Proficient in the use of Microsoft 365
• Excellent organizational skills
• Ability to juggle multiple projects and tasks at the same time

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:

• 10 annual paid holidays
• 120 hours of paid time off annually
• 100% of the employee premium for health and dental insurance, option to add family
• Retirement plan with company match
• Education benefits in the form of tuition assistance

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.