Evimeria, part of Carasent is on an exciting journey within e-health and innovation, and we want to strengthen our Quality Team with a Regulatory Affairs specialist focusing on MDR transfer for our medical device software products, to support our vision of Enabling future care. We strive to build and implement our common procedures and ways of working within the Carasent Group to enable and support organizational growth, product development and delivery of e-health solutions, as well as compliance to regulatory requirements and our MDR transfer. You'll be working from our Gothenburg Office but will support Carasent - together with the Quality Team.
We are in a scaling phase and growing rapidly within Carasent, building a new Quality Team and our new Carasent Management system (quality and information security) to support our MDR transfer, therefore we are searching for a Regulatory Affairs specialist with an interest in regulatory requirements related to products, conformity assessment, regulatory applications/submissions, and approvals for medical device. We collaborate in the Quality Team, as well as interacts with all functions, but you will take the lead in the development and implementation of the Regulatory compliance procedures regarding medical device strategy, classification, GSPR checklist, technical documentation summary and MDR/RA codes (e.g., BUDI, UDI). Regulations per market as applicable.
Challenges to handle
- Process owner of Regulatory Compliance (SOP, WIs and templates as applicable)
- Act as RA in product development projects, support/input to organization in interpretation of regulatory requirements related to SaMD/MDSW (class I and IIa), including label and instruction for use.
- Create regulatory strategy, MDSW qualification and classification, coordinate TD summary, coordinate GSPR checklist. Participate in Design reviews and relevant documents reviews from RA perspective.
- Regulatory submissions and applications in applicable markets (e.g., EU, U.K.), including EUDAMED.
- Subject matter expert (SME) for RA-related in MDR within the Carasent Group.
- Experience from QA/RA related to regulatory requirements, product compliance and conformity assessment for MDD/MDR. Merit if knowledge of medical device software, and even better standalone software (SaMD/MDSW).
- Knowledge and understanding of common standards and Regulations for Medical device, e.g., MDD/MDR, EN ISO 13485. Plus is knowledge of regulations GDPR and PDA, as well as standards related to risk management (ISO 14971), software development (e.g., IEC 62304, IEC 82304-1, IEC 62366-1), information for users (ISO 20417, ISO 15223-1) and information security (e.g., ISO 27001).
- Experienced from reading and interpreting Regulations.
- Quality assurance mindset, structured and orderly.
- Easy to communicate, collaborate, coordinate and give support/trainings.
- Full professional proficiency in Swedish, excellent English skills, written and spoken
What's in it for you?
- An opportunity to be a part of scaling company with the aim of making a big impact on the global healthcare sector
- Development opportunities within a dynamic and fast-growing company
- Competitive compensation and good benefits
- 2 wellness hours every week + a wellness allowance
- 6 weeks of vacation + bridging days
- Environmental bonus, when choosing a climate-friendly transportation to the office
- Flexible working hours and freedom to partly work from home
Your manager for this position will be Ankie Sjöberg, Quality Assurance Director, Carasent. For questions about this position please contact Ankie Sjöberg firstname.lastname@example.org or Kajsa Conradi, Chief People Officer, email@example.com.
Carasent is a group focused on developing high-quality e-health solutions for the healthcare sector. Several of our systems are Electric Health records systems (EHR) which are medical devices. Through our subsidiaries, we want to enable people and synergies. We believe in innovation that offers a new kind of accessibility and availability for patients and practices. We offer intellectual and financial capital for stakeholders that want to provide high-quality services in this area of digital transformation.
Our journey started in the spring of 2018 when Carasent, acquired Evimeria EMR AB,a Swedish company that delivers web-based solutions within health. Our growth is based on providing our customers with modern and value driving solutions. Today, Carasent consists of around 160+ employees in Evimeria EMR AB, Avans Soma AS, Metodika AB and Medrave AB