Philips Regulatory Affairs Specialist m/w/d Medical Device 

Germany, Baden-Württemberg 

456246484

Regulatory Affairs Specialist (m/w/d) Medical Device

Your role:

• Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy for new product introduction

• Responsible for worldwide product registration submissions/approvals as well as license renewals and updates.

• Prepare FDA and Health Canada submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions.

• Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed

• Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.

• Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations

• Provide Regulatory support for Audit, IIA and CAPA

You're the right fit if:

• Technical degree in engineering or scientific discipline -such as Biomedical Engineering, with clear understanding of the multimodality systems

• 2-3 years´ plus professional experience in medical device product Quality or Regulatory, R&D, -specially dealing with regulatory aspects product development, design control related deliverables

• First professional experience in regulatory affairs or in quality management systems related to medical devices.

• Knowledge of regulatory standards (e.g. IEC 60601 series, IEC 62304, IEC 62366, ISO 14971)

• Experience working with technical documentation under MDD and MDR beneficial

• Fluent in English

• Cross-functional influence and advisory experience is helpful

Indicate if this role is an onsite role.

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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