SENIOR REGULATORY AFFAIRS SPECIALIST FOR °MEQU

˚MEQU; København; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

°MEQU in Copenhagen is seeking a Senior Regulatory Affairs Specialist to join the QA & RA Department. You will own regulatory processes and drive compliance for medical devices in a fast-growing MedTech scale-up.

The role involves collaboration with RA/QA, R&D, Operations, Sales and Marketing to ensure design control, documentation, and market approvals. A degree in engineering or MSc and several years in regulatory affairs are required.

Qualifications

• Several years of experience in regulatory affairs for medical devices.
• Degree in engineering or MSc in a relevant field.
• Experience working with RA processes and documentation.

Responsibilities

• Lead vigilance and post-market surveillance inputs with Sales, R&D, QA and other stakeholders.
• Collaborate with R&D on design control and design change projects, set regulatory strategy.
• Support electronic document management and ensure up-to-date quality documentation.
• Assess regulatory requirements for MEQU products entering new markets; drive market approvals.

Skills

Regulatory affairs

Medical devices

RA processes

Cross-functional collaboration

Education

Engineering degree

Master of Science

Tools

EUDAMED

GUDID

Job description

SENIOR Regulatory affairs Specialist for °MEQU

Join a fast-growing MedTech scaleup

This is an exciting opportunity to join °MEQU during a period of exiting growth and development. We are looking for a highly motivated and experienced Medical Device Regulatory Affairs Specialist to play a key role within our QA & RA Department.

Seize this opportunity if you want to be part of our dynamic team in Copenhagen and help us shape the future of critical care.

At °MEQU we empower healthcare professionals to save lives with our innovative °M Warmer System; a sterile portable blood and intravenous (IV) fluid warmer that heats fluids to body temperature within seconds. The system is trusted in the most demanding environments, such as military forces, emergency medical services, rescue helicopters, and hospitals globally. We achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024. As we continue our growth and expand into new markets, we are committed to delivering cutting-edge, user-friendly healthcare solutions.

We have offices at Symbion, Fruebjergvej 3, 2100 Copenhagen.

The role you will fill

As our new Regulatory Affairs Specialist, you will be part of the growing QA & RA Department and report to the Chief RA/QA Officer in °MEQU. The position involves responsibility for specific RA processes, ensuring the operation, continuous development, training of the organization etc. together with your RA colleagues.

The company complies with the following overall Quality Management System requirements for Medical Devices: ISO 13485:2016, MDD/MDR, FDA, UKCA, TGA, Japan MHLW MO169

THE POSITION

As a Regulatory Affairs Specialist, your main job-areas and responsibilities will be:

• Vigilance process, involving collaboration with Sales, R&D, Operation, QA and other stakeholders in relation to assessing complaints for reportability and potentially reporting to the authorities. It will also involve ensuring input to Post Market Surveillance Process.
• Acting as RA partner for R&D for Design Control and Design Change Project, cost saving projects and development of the next generation of products. This includes responsibility for the regulatory strategy and ensuring technical documentation such as STED/GSPR/EC Declaration of Conformity and more.
• Support the implementation of an electronic document management system for specific RA processes.
• The job will also include updating and maintenance of quality documentation, such as procedures, instructions, and forms - including continuous process improvement and monitoring of process effectiveness.
• Monitoring of external requirements and ensuring interpretation and implementation in the processes and/or products as applicable. The work will include collaboration and stakeholder management with relevant partners in the organization.
• Training of the °MEQU organization in both general and specific RA processes and subjects.
• RA partner in assessing requirements to MEQU products and processes when entering new markets, this includes collaboration with local subject matter experts in MEQU. Driving market approval application processes according to the regulatory strategy.
• Support the Master data process cross functionally including managing uploads to FDA (GUDID), EU (EUDAMED) and other countries.

ABOUT YOU

You have several years of experience from a similar position within RA, ideally from a company within the Medtech business. You are now ready to join a young and vibrant MedTech scale-up company and contribute to the fast development of your own area of responsibility as well as the cooperation across the organization.

That you hold a degree in Engineering, Master of Science, or a similar technical education in a MedTech relevant field

You have experience from a RA position within medical device development and have a strong understanding of the relevant regulatory requirements.

As a person, you enjoy working independently, trying new things, and managing a working day with deadlines and changeability.

It will be an advantage if you know the requirements for working in a set-up with contract production, as well as sterilization and production in clean rooms, and experience with electromedical devices.

°MEQU is characterized by a strong culture of cross-functional collaboration and a striving to constantly optimize working processes. You will work closely with colleagues in RA/QA, R&D, Operations, Sales and Marketing.

Since the company is undergoing development with increased growth, it must be expected that the job description can be continuously adjusted with more and/or other tasks.