Director Clinical Affairs, Surgical Systems

Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. You now have the chance to join Oticon Medical for an exciting opportunity leading a group within the Clinical Affairs team.

As Director Clinical Affairs you will lead a team of six highly skilled people with broad responsibilities, and you will be a part of the Clinical Affairs and Product Management leadership team. You will play a key role with responsibility for all clinical activities related to implants and surgical aspects. You will help us to set the strategical direction of our clinical evaluation plans, clinical study roadmap and build clinical documentation for our current Bone Anchored Hearing System (BAHS). You can also look forward to taking part in bringing completely new products to the market – and lead the clinical work that allows that.

This position is based at Oticon Medical AB in Askim and you will become part of an interdisciplinary environment at Oticon Medical’s offices in Gothenburg and Copenhagen, Denmark.

Responsibilities in detail

• Leading a team of Clinical evaluators, Clinical trial managers and Clinical specialists.
• Resource allocation and competence development of your team, but also participating in the work hands-on where and when needed.
• Sparring partner for creating clinical evaluation and PMCF plans on implants & surgery.
• Designing the clinical study roadmap, with responsibility for the area of BAHS implants and surgery.
• Ensure execution of the clinical study roadmap, including sponsored and investigator-initiated trials.
• Drive the constant implementation and development of our procedures for clinical trials and related activities.
• Work in close cooperation with our R&D, QA/RA and marketing groups. In the Clinical Affairs team, you will work closely with your future colleague leading a similar team in Copenhagen, but responsible for audiology & sound processors.
• Be an active member of the Clinical Affairs and Product Management leadership team.
• Take part in building relationship with and connecting to researchers in the field.

Your qualifications

• Relevant academic background (typically a Master’s degree in biomedicine, biomaterials, engineering or similar).
• Experience in leading a team and project manage in a matrix environment with many stakeholders.
• Experience with clinical evaluations of medical devices.
• Experience with both pre- and post-market clinical trials.
• Excellent working knowledge of relevant regulations, e.g. ISO14155, relevant MEDDEV’s, MDD/MDR.
• Preferably knowledge of bone anchored or other hearing devices.
• Experience in usability engineering and/or product development is an advantage.
• Fluent in English

Your personal traits are of great importance. We are looking for a team player who finds it inspiring to discuss challenges with colleagues and employees, but who certainly is someone who can also initiate and make sure tasks gets done. Stakeholder management and having a million balls in the air comes naturally to you. You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, results oriented and get things done. You have an eye for the detail as well as an overview. Your colleagues show confidence in you because you possess a high personal integrity and because you are a good project manager.

What we can offer you

We will give you the opportunity to further develop in our company as our product range and Oticon Medical grows. We are an extremely successful company – the fastest growing company in the fastest-growing segment of hearing healthcare. We are proud of being scientific- and business-driven at the same time, with the expectation of constantly producing best-in-class products. You will enter a culture of being entrepreneurial and driven, but within a larger company. We can guarantee a job that will be extremely varying, stretching from strategic directions to the hands-on execution of clinical trials.

Application and contact
This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter in English or Swedish to karin.tomin@moveup.se

If you have questions regarding Oticon or this open position, please contact Karin Tomin at +46 (0)733 44 09 00

We look forward to your application!

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.