Manager or Senior Manager, Quality and Regulatory Affairs (Consulting)
Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
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
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
Other details
- Job Family Regulatory Affairs
- Job Function Regulatory Affairs
- Pay Type Salary