Abbott looking for Associate Director Regulatory Affairs (Russia/CIS & Eastern Europe Medical devices).
PRIMARY JOB FUNCTION
Lead and support the management and implementation of regulatory processes associated with the placing Abbott products for all Abbott Medical Business Units (CAHF, SH, NMD and VASC) on the market in Eastern Europe, Russia, and CIS Countries. Ensure that all regulatory compliance requirements are fulfilled.
Acts independently to identify and resolve problems at a local and Regional level.
CORE JOB RESPONSIBILITIES
The core responsibilities of this role are:
Regulatory lead for Eastern Europe, Russia, and CIS Countries.
Participate in the development and implementation of regulatory strategies to support EMEA business objectives across all Abbott Business Units.
Develop detailed knowledge of national legislation regulating the placing on the market of medical device in the region.
Liaise with the Abbott EMEA QA/RA Departments and International/Business Units as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
Responsible for leadership, guidance and development of 5 RA staff. Maintain in depth knowledge of medical device laws and regulations in the region.
In cooperation with the business leadership and Business Unit Regulatory Affairs staff ensure that products are registered according to marketing plans and ensure appropriate language/labelling requirements are met.
Provide full visibility of ongoing product registration activities using established trackers and databases, include EMEA and International RA SharePoint sites.
Ensure that notification of the placing on the market is performed by distributors when required and maintain records.
Provide support in the region across all Business Units with tenders.
Develop and maintain knowledge of public procurement legislation, support submission process and ensure RA/QA information is provided in a timely fashion.
Maintain good relationship with distributors, consulting agencies, testing laboratories and regulatory authorities.
Provide training on regulatory requirements as required.
Participate in regional and local trade associations and keep abreast of regulatory developments. Ensure timely communication on new developments and implement regulatory strategies to ensure compliance.
Maintain registration licenses and ensure central secure archiving of any original registration files where required and submitted certification.
Manage launch of new products in the region in accordance with Business Unit objectives.
Support auditing of the manufacturing facilities for the purpose of registration submissions and approvals.
Address GTS license blocks with concerned Business Units.
SUPERVISORY/MANAGEMENT RESPONSIBILITIES
This is a pivotal and critical role in a complex region and is responsible for five (5) staff including RA Specialists and Senior RA Specialists. These staff are currently located in Russia, Serbia and Ukraine.
POSITION ACCOUNTABILITY / SCOPE
This position reports into the Director Regulatory Affairs, EMEA.
This position is expected to manage and be responsible for management of local regulatory budgets for the team/region, including management of registration fees and outside services including working with regulators, regulatory consultants, and type testing laboratories. A good working knowledge of managing and working with these entities is required.
A good working relationship with the Commercial organization and internal stakeholders including Business Unit regulatory colleagues is required
This position is responsible for managing the relationship with external regulators and presenting “One Abbott” externally, as well as with consultants and test laboratories.
MINIMUM EDUCATION
Strong science based technical or clinical background.
Education in biomedical science, engineering, pharmacy or any other applied natural sciences, with a proven track record of regulatory experience in the medical device industry is needed.
MINIMUM EXPERIENCE/TRAINING REQUIRED
Knowledge of regulations of markets in Russia/CIS and Eastern Europe is required.
Minimum 5 years’ experience in a similar role in regulatory affairs or clinical covering Russia, CIS countries and Eastern Europe is needed
Experience of working within the context of a certified Quality System and regulated environment is desirable.
Competent user of Microsoft packages
Knowledge of Abbott product areas/devices is desirable
Excellent all-round communication and organization skills a must
Fluent in Russian and English
Precise and detail-orientated, able to work with sensitive and confidential information ensuring details remain highly confidential
Demonstrated leadership skills, robustness and stress resistance required to manage this dynamic and exciting region.
Strong communication skills and the ability to negotiate with consulting agencies and regulatory bodies is required.
