Regulatory Affairs Senior Manager - Medical Devices

Philips; Blumenau; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A health technology company in Blumenau is seeking a Regulatory Affairs Senior Manager to lead regulatory strategies for health informatics solutions. The role requires a strong background in regulatory submissions and compliance with global standards, including FDA and CE Marking. The ideal candidate will have a Bachelor's degree in Regulatory Affairs or a related field and excellent communication skills. A full-time onsite presence is required.

Qualificações

• Strong professional experience in regulatory affairs within medical device or health informatics environments.
• Proven expertise in global regulatory submissions (FDA, 510(k), CE Marking, etc.).
• Experience with software as a medical device (SaMD) is highly desirable.

Responsabilidades

• Develop and implement regulatory strategies for Acute Care Informatics.
• Lead regulatory submissions for product approvals.
• Ensure compliance with global regulations.

Conhecimentos

Regulatory submissions

Communication skills

Leadership

Stakeholder management

Fluent English

Formação académica

Bachelor's degree in Regulatory Affairs or related field

Master's degree or RAC certification preferred

Descrição da oferta de emprego

Job Title Regulatory Affairs Senior Manager – Medical Devices Job Description

? Blumenau SC

As Regulatory Affairs Manager for Acute Care Informatics, you will lead regulatory strategy and ensure compliance for health informatics solutions and electronic medical records. Your role includes meeting global regulatory standards (FDA, EU MDR, CE Marking, etc.), managing submissions, and supporting new product launches and lifecycle activities.

Your role

• Develop and implement regulatory strategies for Acute Care Informatics and EMR products, ensuring process harmonization.
• Lead regulatory submissions for product approvals (e.g., FDA 510(k), EU MDR) and manage market access.
• Ensure compliance with global regulations and oversee Quality Management System improvements.
• Advise cross-functional teams on regulatory requirements for new products and changes.
• Represent the company in audits and regulatory interactions while mentoring the regulatory team.

Required Qualifications

• Bachelor’s degree in Regulatory Affairs, Engineering, Life Sciences, or related field (Master’s or RAC certification preferred).
• Fluent English - this position will report to a global team.
• Strong professional experience in regulatory affairs within medical device or health informatics environments.
• Proven expertise in global regulatory submissions (FDA, 510(k), CE Marking, etc.).
• Experience with software as a medical device (SaMD), informatics platforms, and hospital management system solutions highly desirable.
• Experience (or practical understanding of) working with medical device and non-device artificial intelligence is highly desirable
• Strong leadership, stakeholder management, and communication skills.
• Ability to work in a large, matrixed organization and collaborate with global teams.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an administrative role based in Blumenau SC.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.