Regulatory Affairs Director

2 hours ago

Kent, United Kingdom SciPro Full time
Job Title: Head of Regulatory Affairs

SciPro is seeking a seasoned professional to lead their regulatory affairs team in the EU. As Head of Regulatory Affairs, you will be responsible for ensuring compliance with EU regulations and guidelines for medical devices and pharmaceuticals.

Key Responsibilities:

  • Act as a liaison between management and regulatory departments to ensure seamless communication and collaboration.
  • Develop and manage regulatory documents, including technical files and dossiers, to ensure compliance with EU regulations.
  • Provide strategic guidance on EU regulatory compliance, including MDR, MDSAP, OTC, and EU Reg 1223/2009.
  • Manage project assignments related to investigational, new, and marketed products, ensuring timely and effective regulatory submissions.
  • Support third-party and competent authority audits, ensuring compliance with regulatory requirements.
  • Gather regulatory intelligence from government agencies and trade associations to stay up-to-date on regulatory changes.
  • Communicate the impact of regulatory changes to the business and global partners, ensuring a proactive approach to compliance.

Requirements:

  • Deep knowledge of EU legislation for medical devices is mandatory.
  • Experience with cosmetics, pharmaceuticals, electrical products, food supplements, or detergents would be beneficial.
  • Familiarity with quality management systems (ISO 22716, ISO 13485, ISO 9001) is essential.
  • Fluency in French would be a plus.
  • Experience liaising with regulatory bodies and working cross-functionally is crucial.

SciPro is a well-established consumer goods company with a strong presence in the US, UK, and Europe. As a member of their regulatory affairs team, you will have the opportunity to work with a talented group of professionals and contribute to the company's success.

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