We are investing in our Quality Assurance and Regulatory Affairs department to be better wired for the future, where we have a strong pipeline of innovative new devices. We have therefore decided to not have one manager for both areas, but instead one for each area. We have already hired a highly skilled candidate for our QA manager and are now looking for our Regulatory Affairs Manager to step into this exciting newly created position.
Are you passionate about regulatory affairs? Do you have experience in the medical device industry? And do you enjoy working in an international environment? Then it might just be you, we are looking for!
As the Regulatory Affairs Manager, you will be responsible for maintaining registrations for our medical device products, and the regulatory demands for the approval of products during the entire development phase. You should support the organization with regulatory advice and help formulate and implement regulatory strategies across different projects. You will be working closely with different departments across the organization and borders, such as marketing (including clinical), R&D, and quality assurance. We have these departments located in our offices near Copenhagen in Denmark and in Sarasota, Florida in USA. You will be working from one of these locations depending on where you live. You will be reporting directly to the CEO.
Mermaid Medical Group is a manufacturer and distributor of medical devices with Nordic roots and headquarters close to Copenhagen in Denmark. We started as a distributor of medical devices with strong partnerships with producers and have in recent years moved into product development and manufacturer of new and innovative products. We are 55 employees spread across Europe and USA. You will have to expect some international traveling.
As the Regulatory Affairs Manager with us, you will amongst other:
- Be responsible for preparing and maintaining pre-market submissions, license applications, and product registrations for medical devices in target countries
- Manage Post-Market Surveillance activities
- Support the organization by designing, developing, and implementing regulatory strategies for new and modified products and regulatory processes, and be responsible for meeting the regulatory demands for the approval of our medical devices during the entire product development phase
- Be responsible for maintaining the communication 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
- Create and finalize Technical File documentation and submission documentation in compliance with the relevant regulatory requirements
- Develop, improve, and maintain the regulatory processes within the Quality Management System
- Work cooperatively with R&D, Quality, Manufacturing, Clinical Affairs, and Marketing on, e.g., CAPA, Internal Audit, and Clinical evaluation process, UDI and labeling requirements, product development, and various complex projects to ensure success
You will be working in different highly skilled international teams to provide advice to other functions.
Who are you?
We expect that you have at least a bachelor’s degree in engineering, science, or a related field and/or medical device experience and that you have a minimum of 5-7 years of experience in Regulatory Affairs in an international company working with vascular medical devices.
The successful candidate has a great sense of responsibility, is reliable with a high-quality standard, and is committed to meet deadlines.
To be successful as the Regulatory Affairs Manager with us, you must:
- Have profound knowledge and experience of the relevant approval rules, i.e., MDR, FDA, and relevant laws and guidelines, such as MEDDEV, applicable standards, etc.
- Be a team player
- Have the ability to perform detailed tasks with accuracy
- Be proficient in the use of Microsoft 365 and preferable ERP
- Have excellent organizational skills
- Have the ability to juggle multiple projects and tasks at once
It would definitely be an advantage if you had the Regulatory Affairs Certification (RAC) or something similar, though it is not a requirement.
We are an international company that requires you to be proficient in English, both written and spoken, to collaborate across the organization. If you will be working out of the Danish office, it will also be a requirement that you are fluent in Danish, both written and spoken, as this is the language spoken at the office in Denmark. It will be preferred if you speak a second European language.
What do you get?
You will enter a newly created position, which provides you the possibility of shaping the role. You will also have the possibility of collaborating across multiple cultures and nationalities, with different functions. We are a company that spans a large geographical area but with fewer employees than most of our competitors, which allows you to enter a more agile workplace and provides you with more freedom and responsibility. We also have some great benefits such as health insurance, company events, and compensation for physical activity subscriptions.
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 or anything 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.
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 does their best to ensure happiness and quality of life, both for the patients who benefit from our products as well as for each other.