Regulatory Affairs Manager Medical Devices
Share
Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Regulatory Affairs Manager - Medical DevicesJob 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:
- Bachelors degree in Regulatory Affairs Engineering Life Sciences or related field (Masters 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
