Clinical Affairs Manager

Sonova is a global leader in innovative hearing solutions: from personal audio devices and wireless communication systems to audiological care services, hearing aids and cochlear implants. We operate through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser (under license) and Advanced Bionics as well as recognized regional brands. At Sonova we create sense by bringing sound to life.

Sonova has more than 18,000 committed employees in over 100 countries, all of whom contribute to something greater than themselves – they transform lives. Join our mission and become part of our team! Apply now for the following position: Clinical Affairs Manager.

Overview: Sonova is seeking a dedicated and detail-oriented Clinical Affairs Manager to support the clinical evaluation of our innovative hearing instruments. As a Clinical Affairs Manager, you will play a crucial role in supporting the market access of our medical devices in ensuring  compliance with company procedures and applicable clinical regulations. This position requires a strong understanding of clinical data and the ability to summarize relevant clinical evidence effectively according to a pre-defined plan.

What you’ll do:

• Support the clinical evaluation process in compliance with Sonova procedures,  EU and further global regulations, including:
  • Planning and scoping the clinical evaluation for the hearing instrument products
  • Identify, appraise and analyze relevant data
  • Assess the safety and performance of devices based on relevant data.
  • Perform risk/benefit evaluations of devices based on the State-of-the-Art.
• Contribute to the creation and maintenance of clinical evaluation documentation, including:
  • Clinical Evaluation Plans, Clinical Development Plans and Clinical Evaluation Reports collaboration with the project team.
  • Plans and Reports for systematic reviews of literature.

• Collaborate with Clinical Affairs Team members to ensure alignment with medical device regulations, best practice and process improvement.

• Support Post-Market Clinical Follow-up activities.
• Support project teams with Claims Management activities.
• Support departments conducting clinical investigations, including:
  • Assisting with requests to ethics commissions and competent authorities.
  • Supporting research sites to ensure adherence to applicable regulations, guidelines, and procedures.
  • Monitor clinical investigations as needed.
• Understand and follow Sonova’s standard operating procedures according to training requirements.
• Share and learn clinical affairs knowledge in communities and expert sessions.

What you bring to the team:

• Experience working with clinical investigations and regulatory matters.
• Experience in Clinical Evaluations according to EU MDR (will be an asset)
• Knowledge running literature searches (eg Lit Search Database: Pubmed, Cochrane, Embase.
• Knowledge of Medical Device industry (nice to have)
• Knowledge of Polarion (nice to have)
• Analytical skills
• Ability to work independently
• Collaborating with interdisciplinary teams
• Time management
• Open and transparent communication

What makes us a great place to work for:

• Exciting and challenging work environment

• Collaborative culture
• Opportunities for continuous self-improvement
• Opportunities for flexible hybrid model work environment
• A company that values diversity and inclusion
• Rich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, etc.) and competitive compensation including variable component and employer match on pension contributions
• Mentorship program and career development plans

Sonova Canada is now a certified Great Place to Work® May 2024- May 2025.

Take a look at how you can Create Sense with us!

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted.  All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.