Clinical Affairs Director

What can you expect from your day with us?

• Provide support to the engineering team in product development.
• Support the Regulatory Affairs area in reviewing or approving documents and liaising with Regulatory Authorities.
• Participate in product development, labeling, and packaging projects, with responsibility for approving verification and validation activities described in PROC 027.
• Approve biological safety assessments in accordance with ISO 10993.
• Approve supplier qualification in accordance with ISO 10993.
• Approve clinical evaluations in accordance with applicable medical device regulations.
• Ensure that clinical programs and research are planned, aligned, conducted, and reported in compliance with national and international requirements, including the new EU-MDR.
• Ensure compliance with all current regulations applicable to the Clinical Affairs & Biocompatibility area.
• Ensure the strategy and operation of post-market clinical follow-up (PMCF) in accordance with MEDDEV 2.12/1 and MDR.
• Proactively collaborate with the Product Research & Development team and other internal departments to ensure the best clinical evaluation process for medical devices.
• Approve updates to work instructions, procedures, forms and new documents in the Clinical Affairs & Biocompatibility area.
• Lead the Clinical Safety and Clinical Support teams.
• Evaluate team performance.
• Lead, seek, and manage interinstitutional contracts aimed at developing clinical studies and biocompatibility testing within the scope of Clinical Affairs & Biocompatibility.

What do you need to have or know?

• Bachelor’s degree in Biomedicine, Pharmacy, or Dentistry
• Preferred: Postgraduate degree, Master’s, or PhD
• Fluent English
• Experience in managerial, administrative, and technical activities in projects within the Clinical Affairs area
• Experience in people management

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.

Confidencial (Apenas para Cadastrados) 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!