Clinical Evaluation Specialist

Straumann Group has been a leader in premium implants for the last 75 years, followed by becoming one of the largest players in entire Implantology market with 4 more brands acquired over more than a decade. The expansion into Orthodontics and digital dentistry has been a focus area for the company over recent years to establish as an oral care company in specialty dentistry. As the company prepares for its rather ambitious 5B Goal, making commercial business models in specialty workflows is the way chosen to become the Experience company focused on the patient in the center of all innovation.

The position is a 100% position as Specialist for Clinical Evaluation according to the European Medical Device Regulation (EU-MDR). The position is located within the Straumann Group Development Center (SGDC) in Curitiba, Brazil, where you will be supporting the registration of newly developed medical devices. You will be working with and functionally reporting to the Straumann Clinical Evaluation Team located at Headquarters in Basel, Switzerland.

What can you expect from your day with us?

• Taking ownership of projects as Clinical Evaluation Representative
• Writing scientific documents incl. Clinical Evaluation Plans/Reports for the registration of Medical Devices according to the European Medical Device Regulation
• Perform and document systematic literature searches to search for clinical data and state of the art overviews for medical devices in Dentistry
• Cooperate proactively with stakeholders across Straumann Group companies to ensure Clinical Evaluation processes for product registration according to defined timelines
• Reviewing relevant input documents for consistency and alignment
• Keep up to date on new regulatory requirements regarding clinical evaluation of medical devices
• Interpretation of clinical data to support the risk benefit ratio of the devices under development

What do you need to have or know?

• University degree (M.Sc. or higher) in a relevant discipline (life sciences, medical, biomedical engineering)
• Work experience in Clinical Evaluation according to EU-MDR/MedDev 2.7.1 or regulatory affairs in medical device / dental industry or service provider
• Excellent verbal and written communication skills in English; please submit your application and CV in English.
• Good organizational skills and ability to build up new competencies
• Focus on continuous improvement and innovation
• Collaboration, engagement, ownership mentality, agility
• Systematic and structured working style
• Good analytical skills and able to interpret data
• Self-motivated, flexible, responsible, and goal-oriented person
• Good knowledge of MS Office applications

What will you find here?

• Meal allowance (food voucher)

• Meal voucher (for restaurants);

• Health insurance with nationwide coverage, extended to dependents;

• Dental plan;

• WellHub (Gympass);

• Transportation allowance or parking subsidy;

• Profit-sharing program (PPR);

• Internal development programs;

• Discounts on our product lines;

• Growth opportunities.

Straumann Group believes in diversity, which is why our job openings are available to everyone, regardless of gender, race, sexual orientation, religion, nationality, age, or disability.
Come with us and help make the world smile!