Are you familiar with ISO 13485 and MDD/MDR or IVDD/IVDR? Do you wish to apply and broaden your knowledge to assist innovative companies in bringing new products to the market? Would you like to be part of a successful and knowledgeable team where your input is valued?

At RegSmart Medtech, we blend regulatory expertise with business insight and technical/scientific knowledge. We have a highly skilled team and provide a supportive and amicable work atmosphere.

Your exact role as a Consultant or Senior Consultant will depend on your qualifications, our clients' needs, and your career goals. While every project is unique with many potential assignments, here are some examples:

• Developing regulatory strategies for medical devices, IVDs, or combination products
• Classifying new products
• Conducting risk analysis and risk management
• Performing gap analyses, such as in the transition from MDD to MDR or IVDD to IVDR
• Engaging with notified bodies and regulatory authorities
• Establishing a quality management system
• Reviewing analytical and clinical performance, as well as scientific validity

RegSmart Medtech is part of the Center of Translational Research group, CTR. We work closely with our affiliate companies specializing in pharmaceutical regulatory affairs & quality, clinical development, toxicology, lifecycle management, and analysis.

Based in Uppsala, RegSmart allows for remote work with significant experience. This full-time, permanent position is with RegSmart Medtech as the employer, and we adhere to a collective agreement.

• Multiple years of professional experience in a relevant field within medical technology or diagnostic products, such as:
• Quality Assurance or Regulatory Affairs
• Assessor at the Medical Products Agency (MPA) or a similar role
• Work at a Notified Body

• In-depth knowledge of:
• IVDD/IVDR or MDD/MDR
• ISO 13485
• Proficiency in English, both spoken and written

For this recruitment, RegSmart Medtech works with Search4S. Contact Recruitment Consultant Anna Rennermalm at +46 707 94 20 05 or [email protected] for more information.

Application Deadline: April 8 2024

Interviews and candidate selection will occur on an ongoing basis. Please apply through the link, not mail.

RegSmart Medtech is a part of RegSmart Life Science, a regulatory & quality consultancy specializing in pharmaceuticals and medical devices. We help navigate the intricate and changing regulatory environments, crafting QA and regulatory strategies in alignment with the latest insights. Our expertise is derived from senior positions at the Medical Products Agency and from experience within small and large enterprises.

We are a highly experienced team of experts with vast regulatory knowledge and strong scientific & technical understanding. We leverage our collective experience to make an impact on every project. With solid financials and high demand for our services, our prospects are bright!

Visit us at www.regsmart.se