Director of Regulatory Affairs

We are assisting SmartCella in finding a flexible, pragmatic, and results-driven professional with extensive experience in Regulatory Affairs for the position of Director of Regulatory Affairs!

About the company

SmartCella is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. The company currently has approximately 80–85 employees and will continue to grow coming years.

SmartCella combines novel delivery platforms, such as the Extroducer®, an endovascular delivery device that enables direct injection to hard-to-reach organs and tissues, with state-of-the-art development and manufacturing of cell therapies. The company operates in two business segments: Targeted Delivery and Regenerative Medicines. 

As Director of Regulatory Affairs, you will be part of the Targeted Delivery division. Please read more about that business segment here! 

About the position

As Director of Regulatory Affairs, you will play a key role in SmartCella’s exciting journey of growth and innovation. You will have the opportunity to make a real impact, contributing to strategic decisions and ensuring regulatory excellence across the organization. You’ll collaborate closely with multiple cross-functional teams, including Product Development and R&D, acting as a trusted partner in bringing innovative solutions to market while maintaining compliance with applicable regulations.

Key responsibilities:

• Person Responsible for Regulatory Compliance (PRRC)
• Develop and manage regulatory strategy for Targeted Deliverys portfolio of Class IIb and Class III products
• Regulatory representative in product development projects, including risk management activities
• Responsible for putting together technical files (together with your colleagues)
• CE-marking and international registrations of products, including FDA filings
• Managing a small team
• Assist in the development and maintenance of the company’s Quality Management System (QMS), including handling of deviations and CAPAs

Who we are looking for

You are a creative problem-solver with a strategic mindset, driven by results and guided by a strong customer focus and solution-oriented approach. With a flexible and pragmatic attitude, you remain grounded and self-assured in your role, enabling you to contribute effectively in dynamic and evolving environments. You are experienced in working closely with product development teams and have contributed to the successful development and launch of new products. Further, you have strong drive and a entrepreneurial mindset with a can-do attitude, willing to “go the extra mile”, if needed. 

Qualifications:

• University degree in field of Medical, Life Sciences and/or Engineering
• At least 5-10 years work experience from Regulatory Affairs and Medical Device. 
• Strong knowledge in MDD/MDR 
• Experience working with Class IIb and Class III medical devices products
• Excellent written and spoken communication and presentation skills in English
• Previous responsibility of leading a team is beneficial

Additional information

This is a full time position at SmartCella

Start date: As soon as possible 

Office location: Tullinge, Stockholm

In our recruitment processes we use continuous selection. This means that we review and process applications for the position and conduct interviews continuously. If you find an interesting position with us, we therefore recommend that you apply for the position as soon as possible. You apply for our positions by registering your CV and answering the selection questions for each position, with us you apply without a personal letter and instead you get the chance to motivate your interest in the position in the questions in the application form.

Do you have any questions about the position?

Please feel free to contact Anna Maria Lindqvist or Olivia Johansson.

Anna Maria Lindqvist: 070 589 23 19 / anna-maria.lindqvist@medhouse.se

Olivia Johansson: 070-250 65 85 / olivia.johansson@medhouse.se

We look forward to receive your application!