Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Regulatory Affairs ManagerJob Description
Job title:
Regulatory Affairs Manager
Your role:
The greater impact of this role.
This role ensures that Philips products comply with global regulatory standards enabling safe and effective healthcare solutions. This directly impacts patient safety accelerates product approvals and supports innovation in medical technology.
Detail elements of the team and stakeholders for this role.
Youll collaborate cross-functionally with Regulatory Affairs Specialists Quality Assurance R&D and Engineering Clinical Affairs Marketing and Product Management to ensure compliance throughout the product lifecycle.
What are the professional and personal opportunities for development within this role
Exposure to global regulatory frameworks (FDA EU MDR ISO standards) Opportunities for international collaboration and cultural exposure
From Health and wellness programs to Work-life balance initiatives a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region.
Youre the right fit if:
1. Experience: Typically requires 10-15 years of experience in the medical device industry with a proven track record of successful submissions.
2. Skills: USFDA 510k submission CE certification EU MDR ISO 13485 ISOCFR 820 Health Canada & CDSCO submission medical device rules 2017 CAPA
3. Education: Bachelors degree in a scientific field (Pharmacy Biology or Chemistry) or Engineering; a masters degree or Regulatory Affairs Certification (RAC) is highly preferred.
4. Anything else: Capacity to manage multiple high-stakes projects simultaneously under strict deadlines.
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.
Indicate if this role is an office/field/onsite role.
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
