Job Description
We are Neodent, a Brazilian brand and leader in dental implants in the country. For over 30 years, we have been contributing to creating thousands of new smiles every day. We are part of the Straumann Group and, in Brazil, we represent the brands Neodent, Straumann, ClearCorrect, and Yller.
Our purpose is to create new smiles every day, and we achieve this guided by a cultural journey and a Protagonist & Learner mindset, which make our employees a high-performance team.
What can you expect from your day with us?
- Support product development process and ensure compliance of development deliverables, which includes, but is not restricted to, review of: product requirements, verification and validation test plans and reports, product claims, product labels and instructions for use, applicability of standards, design Review milestones
- Compile the RA Strategy
- Assuring that the technical documentation supporting the CE mark complies with MDR EU 2017/745
- Create and maintain Technical Files and perform conformity assessment for EU according to MDR EU 2017/745
- Ensure compliance with other RA relevant matters of MDR EU 2017/745 (e.g. EUDAMED, UDI, local registration CE+, information to distributors)
- Create & submit registration files for US & Canada
- Ensure compliance with relevant US & Canadian regulations
- Ensure compliance with other RA relevant matters of EU and NAM regulations (e.g. databases, change notification, information to distributors, etc)
- Support during Audits
- Interaction with authorities, notified bodies and any other approving bodies that will be relevant
- Support/assess change requests in accordance with MDR EU 2017/745, US & Canadian regulations
- Classification of the medical device in accordance with MDR EU 2017/745, US & Canadian regulations
- Provide support in regard of interpretation of regulatory rules/laws/guidelines
- Support implementation of new regulatory requirements
What do you need to have or know?
- Technical or scientific graduate degree
- Professional experience in Regulatory Affairs and/or Quality Management
- Fluent (written and spoken) in English
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.
Neodent 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!