Regulatory Affairs Specialist

21 hours ago

Athens, Attica, Greece Healthcare Company Full time €104,000 - €130,878 per year

A dynamic and well-established company in the field of medical devices and healthcare products is seeking a Regulatory Affairs Specialist for full-time employment.

Job

Description

  • Ensure product compliance with applicable national and international regulatory frameworks (MDR, IVDR, PPE).
  • Prepare and maintain technical files for medical devices, cosmetics, and personal protective equipment.
  • Communicate with relevant authorities and organizations regarding registration, notification, and certification matters.
  • Monitor changes in legislation and inform internal departments.
  • Participate in quality control processes, inspections, and certification renewals (ISO 9001, ISO 13485, etc.).
  • Review packaging and layouts for regulatory compliance.

Necessary qualifications:

  • Degree in Health Sciences, Chemistry, Biology, or related fields.
  • At least 3 years of professional experience in a similar position.
  • Very good knowledge of regulations MDR 2017/745, IVDR 2017/746, PPE 2016/425.
  • Excellent command of English (written and spoken).
  • Strong organizational skills, attention to detail, and effective time management.

Preferred qualifications:

  • Experience with certification processes or at a certification body.
  • Familiarity with CRM systems and document management tools.

Benefits

  • Stable work environment with career advancement prospects.
  • Continuous training and skills development.
  • Private insurance.
  • Competitive compensation package.

Desired

Profile

  • Communicative, organizational, self-motivated personality
  • Ability to effectively manage time
  • Attention to detail
  • Positivity, "I can do attitude"
  • Continuous willingness to improve and acquire knowledge
  • Team-player
  • Fluent in Microsoft Office applications and CRM software

Job

type:

  • Daily commute at the premises of the company.
  • Open-ended contract

Some info about the recruiting procedure:

The procedure includes three phases:

  1. Telephone Interview

  2. Interview at the company's premises

  3. Final interview

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