Regulatory Affairs Specialist

vor 2 Wochen

Bayreuth, Bayern, Deutschland medi GmbH & Co. KG Vollzeit

About medi GmbH & Co. KG

medi GmbH & Co. KG is a leading global manufacturer of medical aids in the healthcare market. We develop innovative solutions for improved quality of life, ranging from Bayreuth to the world. Our mission is to enable users and patients to achieve maximum therapy results in the medical field (medi Medical) and a unique body sensation in the sports and fashion segment (CEP and ITEM m6).

Your Role: Regulatory Affairs Specialist

We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our Quality Management Team. In this part-time role, you will play a crucial part in ensuring that our medical devices comply with all relevant national and international regulations.

Responsibilities:

  • Provide comprehensive support to the Regulatory Affairs team in all aspects of global regulatory compliance for medical devices.
  • Conduct thorough research and monitoring of evolving national and international standards, laws, and guidelines related to medical devices.
  • Collaborate with the team to define necessary requirements for our company and medical products based on regulatory frameworks.
  • Assist in the preparation, execution, and follow-up of audits conducted by certification bodies and inspections carried out by regulatory authorities.

Your Profile:

  • Possess a commercial background with training ideally in law, economics, medical technology, or medicine.
  • Demonstrate a strong understanding of medical device regulations and guidelines.
  • Ideally, possess familiarity with Quality Management Systems (QMS) and Project Management methodologies.
  • Exhibit excellent written and verbal communication skills in both German and English.
  • Display autonomy, problem-solving abilities, and a structured approach to work.
  • Possess a strong sense of responsibility, reliability, analytical thinking, and teamwork skills.

What We Offer:

  • Become part of a leading global company in the medical aids industry.
  • Receive comprehensive training tailored to medi's world, where diverse projects and challenging tasks await in an international environment.
  • Join a highly motivated team that embraces daily challenges.
  • Support for selected training and seminars to enhance your professional and personal development.
  • Enjoy attractive discounts at various retailers, sports clubs, fitness studios, and online platforms as a medi employee.
  • Promote your optimal work-life balance with 30 days of vacation, opportunities for sports, healthy eating, and a supportive work environment. Additionally, explore the option to arrange a flexible mix of on-site work and remote work in consultation with your supervisor.
  • medi advocates for work-life balance: we assist with childcare in daycares or kindergartens and holiday care.
  • Live and work in the beautiful Oberfranken region, known for its high leisure value and short distances.

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