Director of Quality Assurance and Regulatory Affairs / Bittium

at  Compass Human Resources Group

Bittium specializes in the development of reliable, secure communications and connectivity solutions leveraging its over 35-year legacy of expertise in advanced radio communication technologies. Bittium provides innovative products and services, customized solutions based on its product platforms and R&D services. Complementing its communications and connectivity solutions, Bittium offers proven information security solutions for mobile devices and portable computers. Bittium also provides healthcare technology products and services for biosignal measuring in the areas of cardiology and neurology. Bittium is listed on Nasdaq Helsinki.
Bittium is looking for a

DIRECTOR OF QUALITY ASSURANCE AND REGULATORY AFFAIRS

Are you a business-oriented QARA leader with in-depth knowledge of medical device regulations and standards, keen to support success through quality assurance and regulatory affairs? We are looking for a dynamic professional to join Bittium Medical Segment as the Director of Quality Assurance and Regulatory Affairs. You can be situated in either Espoo, Kuopio, Tampere or Oulu.

QUALIFICATIONS:

• A suitable university degree / higher education in science or technology.
• Minimum of 10 years of experience in the medical industry and QARA
• In-depth knowledge of medical device regulations and standards (incl. MSDAP, ISO 13485, MDR, FDA).
• Experience with medical device quality control processes (NC, CAPA, PMS, trending, etc.).
• Experience working with Regulated Bodies, Notified Bodies, and relevant authorities in multiple countries is essential.
• Proven experience in leading teams and managing complex situations.
• Excellent problem-solving skills and situational management abilities.
• Strong team player with exceptional communication and leadership skills, and experience working in the customer interface.
• Proficiency in strategic thinking and expertise in business enablement
• Fluency in Finnish and English is required.

As the Director of Quality Assurance and Regulatory Affairs, you will play an important role in integrating qFuality assurance and regulatory affairs into the business strategy. You will be at the forefront of building and leading the Quality Assurance and Regulatory Affairs team and processes. You will ensure that the operations comply with medical device legislation while viewing quality as a broader concept, working in the customer interface and encompassing customer satisfaction, technical quality, process quality, and operational excellence.
You will be responsible for understanding and implementing legislation and authority requirements relevant in business and coordinating compliance and compliance development. Managing interactions with Regulated Bodies, and Notified Bodies will be a crucial part of your role, as will developing and implementing innovative strategies to continuously improve overall quality and compliance.
You will coordinate compliance initiatives across the organization and drive compliance development. Your excellent problem-solving and situation management skills will be essential as you lead the team. Moreover, you will foster a collaborative and communicative team environment, leveraging your strong leadership abilities to inspire and guide your team towards excellence.