Manager or Senior Manager, Quality and Regulatory Affairs (Consulting)

What You Will Do:

• Provide strategic and hands on regulatory support to clients related to compliance (Reg. EU 2017/745 (MDR), Reg. EU 2017/746 (IVDR), MDSAP, ISO 13485, US CFR Title 21, QSR)
• Assess complex scientific / technical documentation to identify gaps and to provide support for improvement
• Manage projects in a structured way in direct contact with Clients, Competent Authorities and Notified Bodies - during audits, conformity assessments and with product specific regulatory issues
• Coach clients on implementation and remediation activities for Quality Management Systems and technical documentation
• Assist clients in successfully managing nonconformities, complaints, recalls, FSN, FSCA
• Participate in Veranex training programs and represent Veranex in congresses and fairs

Qualifications

Required Skills:

 Manager Level:

• Graduate degree in life science, medical or engineering (MSc/PhD) 
• Minimum 3-5 years’ relevant experience in Quality and/or Regulatory Affairs in relation to the medical device / in-vitro diagnostic industry
• Good understanding of regulatory requirements for the market clearance of medical devices/in-vitro diagnostics (EU and/or USA) and/or ISO 13485 QMS implementation
• High-level of professionalism, including strong verbal and written skills
• Strong ability to independently manage tasks and take initiative
• Efficient multitasking and proactive engagement across various responsibilities
• Excellent command of Swedish and English, both oral and written (any other language skills are a plus)

Senior Manager Level:

• Graduate degree in life science, medical or engineering (MSc/PhD) 

• 6+ years relevant experience in Quality and/or Regulatory Affairs in relation to the medical devices/in-vitro diagnostic industry
• Strong understanding of regulatory requirements for the market clearance of medical devices/in-vitro diagnostics (EU and/or USA) and/or ISO 13485 QMS implementation
• Experience interfacing with regulatory authorities to manage submission processes through device commercialization
• Experience overseeing/preparing regulatory strategy packages
• High-level of professionalism, including strong verbal and written skills
• Strong ability to independently manage tasks and take initiative
• Efficient multitasking and proactive engagement across various responsibilities
• Excellent command of Swedish and English, both oral and written (any other language skills are a plus)

Preferred:

• Experience in Quality and/or Regulatory Affairs consulting