Clinical Evaluation Manager

Are you an enthusiastic and dedicated professional with a passion for contributing to the healthcare sector?
Discover a career with the Medicontur, a thriving European company of over 450 employees with a rich 35-year history of excellence.

About Medicontur:
Medicontur is a leading producer of ophthalmic medical devices, with over 7 million intraocular implants produced and sold. Our products are distributed in over 100 countries, providing world-class optical quality lenses and achieving growing market shares globally.
Headquartered in Zsámbék, Hungary, among others we house manufacturing facilities, R&D, logistics, and quality management departments. We also have local offices in the Czech Republic, France, Spain, and Hungary.
What sets us apart is our commitment to innovation, quality, and patient-centric solutions, transforming lives through groundbreaking technology and dedication to improving global healthcare.

Working with us:
At Medicontur, we unite diverse talents from various professional backgrounds, fostering an environment that champions innovation, safety, and cutting-edge technology. The company's forward-thinking approach ensures that employees are part of a dynamic environment where new ideas and individual insights are always given plenty of space.
Here, your skills and ideas are not just welcomed; they are the driving force behind transformative advancements.
This is your chance to be part of a journey that transforms not just careers but lives. Come, be a catalyst for change at Medicontur!

Our mission is freedom of vision, our collective passion is enhancing the quality of life.

To support the growing market demands, Medicontur is now looking for an ambitious:

• Responsible for evaluating clinical data for Medicontur's medical devices, developing and updating documentation of clinical evaluation and post-market clinical follow-up, and
• Scientific and regulatory content writing
• Update clinical evaluation plans, clinical evaluation reports to assess safety and clinical performance clinical data;
• Perform post-marketing surveillance activities, review and write PMS documentation;
• Update PMCF plans and reports, summaries of safety and clinical performance;
• Conducts active PMCF activities (e.g. PMCF investigations);
• Develop clinical investigator brochures presented to regulatory authorities;
• Interfaces with regulatory affairs, risk management, clinical study site personnel, competent authorities;
• Develop and update QMS procedures and document templates describing the clinical evaluation activities.

• Excellent knowledge of MDR requirements, with experience with their practical application,
• University (MD, Dr. Pharma, MSc) degree (preferably a scientific/medical background),
• 2+ years’ work experience in medical writing, preferably in the medical device sector,
• Ability to interpret complex clinical data, together with the good understanding of statistics,
• Fluent English in written and spoken form, MS Office strong user-level,
• Professionalism, proactivity, precision, endurance, flexibility and prioritization skills,
• Ability to work independently, problem solving and communication skills.

Your performance will be recognised with a range of benefits in addition to your basic salary:

• Cafeteria: gross annual cafeteria allowance of HUF 729.600 (can be used for SZÉP card, pension fund, health fund or Wáberer Medical private health service)
• Bonus: Annual payment under the MRP (Employee Share Ownership Plan)
• Family support: daycare (gross HUF 300.000 /year), kindergarten (gross HUF 150.000 /year) and school allowance (HUF 30.000 /year)
• Travel to work allowance: in the form of a fuel subsidy (HUF 40/km) or 100% travel pass subsidy
• Company phone and laptop
• Dental discounts for Medicontur employees at our premium dental partner
• Vision allowance: you can get a subsidy every 2 years when you buy glasses frames or contact lenses
• Life and accident insurance: taken out with Allianz Insurance for all our employees
• Referral reward: through our "Refer a friend" referral scheme, successful referrals are rewarded with a referral reward
• All You Can Move Sportpass (AYCM) possibility
• METRO card: discounted shopping opportunities