Philips
Regulatory Affairs Manager
As a Regulatory Affairs Manager, you will provide strategic input during the product creation process and support the development of the department’s overall regulatory strategy plan. In this role, you will closely collaborate with Product Development, Medical/Clinical Affairs, and Marketing and Sales. We are looking for a regulatory affairs expert with experience in medical device submissions (FDA, Health Canada, EU, etc.) who is eager to take on the challenge of coaching and leading an RA project team while driving new product introductions, maintenance projects, and process improvements.
Key Responsibilities:
Provide specialized expertise in regulatory science, including global regulatory matters across diverse product categories such as implants, software, combination products, and biologics.
Develop and influence global regulatory policy while ensuring compliance with evolving regulations.
Lead the preparation and submission of regulatory documentation, including FDA (510(k), IDE, Pre-submissions), EU (Technical Files/Design Dossiers), Health Canada, and other global regulatory submissions.
Work under limited supervision while contributing to the development and execution of organizational policies impacting business operations.
Coach and mentor a diverse regulatory team, fostering skill development and ensuring individual and team goals are met.
Apply advanced analytical skills to solve complex regulatory challenges and develop innovative strategies based on limited information and precedent.
Establish and maintain strategic partnerships with internal and external stakeholders to enhance regulatory processes and compliance.
Qualifications:
Bachelor’s or Master’s degree in a relevant scientific discipline.
Minimum of 5 years of experience in regulatory strategy development for medical devices, supporting submissions and market introductions.
Proven experience in leading regulatory affairs projects and ensuring required documentation for regulatory submissions.
Strong knowledge of medical device regulations, including FDA laws and product registrations.
Experience with successful preparation and submission of 510(k) applications and global medical device registrations.
Extensive experience with regulatory requirements for medical devices, with software and artificial intelligence experience preferred.
Project planning and management skills are a plus.
Strong verbal and written communication skills in English, with excellent interpersonal and team collaboration abilities.
What We Offer in Return:
Collaborative Environment: Join a dynamic and multicultural team focused on delivering excellence in regulatory affairs.
Professional Growth: Access training and development opportunities within a global organization.
Global Impact: Contribute to regulatory strategies that support high-quality healthcare solutions worldwide.
Additional Information:You will work for Philips as a contract or permanent employee of a Randstad company, gaining access to benefits and career development opportunities.
About Philips:Philips is a health technology company built on the belief that every human matters. We strive to ensure everyone has access to quality healthcare and innovative solutions. As part of our team, you will contribute to life-changing projects that improve lives worldwide.
If you’re interested in this role and have many, but not all, of the required qualifications, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion.