Regulatory Affairs Specialist IVD

Job description

     

JOB DESCRIPTION:

Main responsibilities :

·  Responsibility for developing a comprehensive registration strategy in close cooperation with the personnel dealing with sales, operations, vaccines and marketing, taking into consideration Company's interests and normative requirements.
·  Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and/or strengths, along with price registration/re-registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).
·  Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
·  Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
·  Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normatine documents related to registration of medicines.
·  Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.
·  Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
·  Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.

Requirements :

·  Higher education
·  At least 2 years of experience in Regulatory Affairs (medical equipment, pharmaceuticals, chemical products)
·  Strong willing to develop in IVD regulatory affairs field;
·  English – written, spoken
·  Excelent knowledge of MS Office (Word, Excel)
·  Personality: team player, well organized, attentive to details, enthusiastic, quick learner
·  Ability to work with big amount of information

Benefits:

·  Medical insurance for the employee and his children (100% coverage);
·  Medical insurance for a spouse (50% coverage);
·  Life insurance (accidents)
·  Food allowances
·  Various training programs
·  Employee assistance programs
·  Compensation costs for fitness (for employees who have been with the company for over 1 year)

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADD Diagnostics

        

LOCATION:

Russia > Moscow : Metropolis Building 1

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists)