regulatory affairs and quality control specialist - χαλανδρι

posted
contact
Dora Tzevelekou, Randstad Hellas
job type
temporary
apply now

job details

posted
location
χαλανδρι, attica
sector
life sciences
job type
temporary
reference number
30793
contact
Dora Tzevelekou, Randstad Hellas
phone
2166001387

job description

Are you looking to launch a career in Biotechnology & Medical Devices?

Do you have experience working as a Regulatory Affairs & Quality control specialist in Medical Device, Biotech Automotive, Aerospace,  environment?

Then don't miss out on the opportunity to become a Regulatory Affairs & Quality control specialist in one of the leaders in health technology (1 year contract with potential to full time contract).

Apply now for the role Regulatory Affairs & Quality control specialist!

benefits

The company offers the following benefits for the Regulatory Affairs & Quality control specialist position:

  • Competitive remuneration package
  • Dynamic working environment

responsibilities

The Regulatory Affairs & Quality control specialist we are looking for, will have a 1 year contract with potential to full time contract. He will coordinate, review, and file new device registration/approvals and amendments to existing products (medical devices and consumer products) for market access into Greece and communicate with relevant competent authorities, agents, distributors and local sales offices to ensure the most efficient path to application approval.

Key Accountabilities

  • Advise local and international teams on the most expedient route to obtaining product licenses, and ensure market access strategy is aligned with local and international marketing/sales requirements. 
  • Support resolution of any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
  • Develop and take the ownership of Greece market submissions
  • Establish active communications with regulatory agencies in Greece
  • Review and approve advertising, promotional items and labeling for regulatory compliance
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Escalate with Italy, Israel, Greece (IIG) RA and businesses regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required
  • Other projects assigned by respective IIG RA manager
  • Knowledge of EU MDR, EU MDD, ISO 13485 as well as any other critical medical devices and consumer product regulatory requirements and activities

qualifications

The ideal candidate for the position will be expected to have the following:

  • Bachelor’s in Science or Engineering.
  • Experience in a medical device, biotech or telecommunications environment.
  • Regulatory compliance and Quality control experience in the medical device or biotech area.
  • Knowledge of applicable EU medical device regulations and other markets 
  • Regulatory submission experience

skills

  • Strong written, verbal, and interpersonal skills to be able to effectively compose agency submissions and complete assignments with minimal supervision.
  • Ability to coordinate between different functions.

experience

  • 1-3 years experience in regulatory affairs, quality control in medical device or biotech env

educational requirements

  • AEI

information

If this sounds like you, we want to hear from you today! Should you need additional information, 

please contact me Dora Tzevelekou at 2166001387.

Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.