Join a Swedish MedTech company revolutionizing electrostimulation for neurological disorders.

Hays Sweden is looking to recruit a Clinical Development Manager for Exoneural Network AB.

Your new company

Exoneural Network AB is a Swedish MedTech company specializing in groundbreaking advancements in the realm of full-body electrostimulation. Our core focus lies in the development, manufacturing, and sale of the EXOPULSE Mollii Suit, a revolutionary product designed to enhance the lives of individuals battling neurological disorders like cerebral palsy, multiple sclerosis, or stroke. Our unwavering commitment is to empower individuals by creating opportunities for active movement, functional improvements, and fostering a dignified and engaged lifestyle for all. By striving to mitigate the effects of spasticity and difficulties in voluntary movement control and pain, we are dedicated to ensuring exceptional quality and minimizing risks through the continuous evolution of our flagship product, the EXOPULSE Mollii Suit.

Your new role

As a member of the Clinical Research team at Exoneural Network AB, your role is crucial in leading clinical trials for products during development, aimed at achieving CE-marking, and in collaborating with the R&D team in clinical validation of products during development. Also, to implement an effective quality management system in accordance with the Medical Device Regulation EU 2017/745 (MDR), in the field of Clinical Product Development.

To excel in this position, we are seeking an ideal candidate with prior experience in MDR and clinical activities within the MedTech industry. Your motivation, drive, and strong individual contribution will be invaluable, along with your exceptional organizational skills, structured approach, and expertise in documentation and literature research.

Responsibilities:

• Manages planning and execution of clinical investigations for CE labeling of new medical devices during the product development phase.
• Supports in clinical validation of products under development, in collaboration with the R&D Team.
• Supports the management of clinical investigations of CE-marked medical devices.
• Supports in assuring compliance with the product documentation related to Design and Development, Clinical Investigation, and Clinical Evaluation in the company's Quality Management System (QMS).
• Maintains compliance with regulations and standards for medical devices with focus on MDR 2017/745 in the EU.
• Maintains compliance with other regulatory requirements such as Good Clinical Practice (GCP) as well as Standard Operating Procedures (SOPs).
• Manages readiness for inspection by regulatory authorities and notified bodies.
• Performs other duties as assigned.

Qualifications

• MSc or Ph.D. in Life Science
• Experience in the Life Science industry, preferably from MedTech
• Experience in clinical trials
• Experience in documentation
• Experience in clinical investigations during product development and/or clinical investigations on outside CE-mark
• Experience in the Medical Device Regulation EU 2017/745 (MDR) is preferred.
• Highly skilled in English and Swedish, adept at communicating fluently and effectively in both written and spoken forms.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV.
Alternatively, you may contact us directly by phone.

For any inquiries related to the position or the application process, please feel free to reach out to the designated recruitment consultant Henna Ton, at [ Link removed ] or 0704 50 60 10.

We will be conducting an ongoing selection process for candidates, so we encourage you to submit your application promptly.

If this particular job does not align perfectly with your preferences, but you are actively seeking a new opportunity, please do not hesitate to contact us for a confidential discussion about your career.