Sr. Regulatory Affairs Specialist

2 maanden geleden

Best, Nederland Philips Voltijd
JOB DESCRIPTION

Job Title

Sr. Regulatory Affairs Specialist (Clinical Informatics)

Job Description

You will be an integral team member of the Clinical Informatics (CI) Regulatory Affairs team and therefore, influence and shape the regulatory capabilities for future success of Philips.


Your role:

Through end-to-end regulatory processes, ensuring safe and effective products / solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.

Compiling registration dossiers, 510(K)s and providing advice on submissions to Product teams.

Provide critical input on regulatory risk assessments to support Business.

Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations.

Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
 

​ You're the right fit if:

Minimum of a master’s degree (or equivalent), in a relevant field with a minimum of 8+ years of experience working in Regulatory Affairs within the medical device industry.

Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier) and experienced in strategic relationships with external stakeholders (e.g., Industry Associations etc)

Experience with Active devices (Class II/Class III devices including Hardware devices), SaMD, AI, digital health, cloud computing and associated development methodologies as well as lifecycle topics is preferable.

Knowledge of MDD, MDR, IVDR, MedDev & MDCG’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, other applicable regulations, standards and application of them.

Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.

An excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes and self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.

An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for solution.

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 role is an office role.
 

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.
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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 commitment to diversity and inclusion .

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