Medical Devices Regulatory Affairs Specialist

QUALIFICATIONS

  • Graduation from Pharmacy, Biology, Chemistry or Chemical Engineering departments
  • Minimum 2 year s of experience in medical device registration is a must
  • Knowledge of local and international registration legislations and regulations
  • Experience in labelling and AW development processes
  • K nowledge about the product s
  • Effective planning and organization skills, attention to details and excellent follow up skills
  • Ability to work transversally with colleagues
  • Good a nalytical thinking and communication skills
  • MS office programs knowledge
  • Advanced level of written and verbal English and Turkish communication skills

JOB DESCRIPTION

  • Coordinate regulatory and compliance processes according to company and local regulatory requirements for medical devices and human medicines
  • Review, preparation, submission and follow-up of regulatory processes for products and ensure maintenance of existing portfolio
  • Coordination of labelling and AW creation processes between various markets
  • Maintain good knowledge of regulatory legislations for different product classifications
  • Contribution and management of internal &external databases
  • Support internal medical activities
  • Ensure compliance for promotional materials according to governmental and company rules

#LI-PFE

Purpose

Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

School of Leaders

We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Regulatory Affairs

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