Director of Regulatory Affairs

vor 2 Wochen

Essen, Deutschland Discover International Vollzeit

We are seeking a highly skilled and experienced Director of Regulatory Affairs to join a very exciting new project. The Director of Regulatory Affairs will be responsible for leading regulatory strategy and ensuring compliance with applicable regulations and standards for our clients Class III AIMDs. This role will play a critical part in guiding product development, obtaining regulatory approvals, and maintaining compliance throughout the product lifecycle.


Responsibilities:

  • Develop and implement regulatory strategies to support the development, registration, and commercialization of Class III AIMDs.
  • Serve as the primary liaison with regulatory agencies, including the FDA, EU notified bodies, and other regulatory authorities worldwide.
  • Provide regulatory guidance and support to cross-functional teams throughout the product development process, including design control, risk management, and clinical trials.
  • Lead regulatory submissions, including premarket approvals (PMAs), investigational device exemptions (IDEs), 510(k) clearances, and CE marking applications.
  • Prepare and maintain regulatory documentation, including technical files, design dossiers, and regulatory submissions.
  • Monitor changes in regulations, standards, and guidance documents to ensure ongoing compliance and assess potential impact on the business.
  • Participate in regulatory audits and inspections, and drive the resolution of any findings or observations.
  • Collaborate with internal stakeholders, including R&D, Quality Assurance, Clinical Affairs, and Marketing, to align regulatory strategies with business objectives.
  • Provide regulatory training and support to internal teams to ensure understanding and adherence to regulatory requirements.


Qualifications:

  • Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
  • Minimum of 8 years of experience in regulatory affairs within the medical device industry, ideally with a focus on Class III AIMDs.
  • In-depth knowledge of FDA regulations (e.g., 21 CFR 820, 21 CFR 814) and international standards (e.g., ISO 13485, ISO 14971) applicable to AIMDs.
  • Proven track record of successful regulatory submissions and approvals for Class III medical devices.
  • Strong understanding of regulatory pathways, including PMA, IDE, and CE marking processes.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with internal teams and regulatory agencies.
  • Strategic thinker with the ability to anticipate regulatory challenges and develop proactive solutions.
  • Experience leading regulatory affairs teams and managing direct reports is preferred.
  • Regulatory Affairs Certification (RAC) is a plus.


Benefits:

The position will offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development within a dynamic and collaborative work environment.

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