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Regulatory Affairs Specialist

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Job Title: Senior Regulatory Affairs Specialist

At Philips Iberica SAU, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing comprehensive regulatory strategies for complex software devices and significant post-market changes.

Key Responsibilities:

  • Prepare and submit regulatory submissions, including US 510(k), EU MDR Technical File, and global/international submissions.
  • Ensure product compliance with local and international regulations and company standards.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Stay up-to-date with changing regulatory requirements and industry trends.

Requirements:

  • Bachelor's or Master's degree in engineering, law, life sciences, pharmacy, medicine, or a related field.
  • 5+ years of experience in the medical device industry, with a strong understanding of regulatory requirements.
  • Fluent in written and spoken English.
  • Proficient knowledge of medical device regulations, including 21CFR, FDA law, MDD, and other global laws and standards.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

Travel Requirements:

May require up to 10% travel annually, with some international travel possible.