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Regulatory Affairs Manager

vor 2 Monaten

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At HARTMANN, we're committed to delivering innovative solutions that make a difference in the lives of healthcare professionals and their patients. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the compliance and regulatory readiness of our products.

In this role, you will be responsible for managing the global submission process for our product portfolio, ensuring that all necessary documents are submitted to regulatory authorities in a timely and accurate manner. You will also coordinate with global colleagues and sales partners to ensure seamless communication and collaboration.

As a Regulatory Affairs Manager, you will have the opportunity to work on a wide range of projects, from product launches to post-market surveillance. You will be expected to stay up-to-date with changing regulatory requirements and ensure that our products comply with all relevant laws and regulations.

If you are a detail-oriented and organized individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity. As a member of our team, you will have the chance to make a real difference in the lives of patients and healthcare professionals.

Responsibilities:

  • Manage the global submission process for our product portfolio, ensuring timely and accurate submission of necessary documents to regulatory authorities.
  • Coordinate with global colleagues and sales partners to ensure seamless communication and collaboration.
  • Stay up-to-date with changing regulatory requirements and ensure that our products comply with all relevant laws and regulations.
  • Collaborate with cross-functional teams to ensure regulatory compliance and readiness of our products.
  • Develop and maintain relationships with regulatory authorities and industry partners to ensure effective communication and collaboration.

Qualifications:

  • Bachelor's degree in a scientific or technical field, such as biology, chemistry, or engineering.
  • Minimum 2 years of experience in regulatory affairs, preferably in the medical devices industry.
  • Strong knowledge of regulatory requirements and guidelines, including FDA and EU regulations.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Fluent in English, with the ability to communicate effectively in a global environment.

Benefits:

  • Competitive salary and benefits package, including health insurance and retirement plan.
  • Opportunities for professional growth and development, including training and education programs.
  • Collaborative and dynamic work environment, with a team of experienced professionals.
  • Flexible work arrangements, including remote work options and flexible hours.
  • Access to cutting-edge technology and tools, including software and equipment.