Senior Registration Specialist (Medical Devices Division) / Sr RA Specialist

About the company

Join Abbott, where you can work on important tasks, grow and develop, take care of yourself and your family, and be yourself and live life to the fullest. The employment contract is concluded with Ankor.

Your tasks

• Preparation and support of registration dossiers for medical devices and IVD products, including amendments and preparation of regulatory reporting
• Interaction with government regulatory authorities on issues of registration and maintaining the registration status of products.
• Regulatory support of the product portfolio at all stages of the life cycle
• Development and implementation of regulatory strategy for new and existing products
• Ensuring timely receipt of registration certificates and submission of registration changes
• Assessment of regulatory risks and development of recommendations for their minimization
• Consulting cross-functional teams on regulatory requirements, registration, labeling, and product market launch
• Regulatory support for projects involving changes in manufacturing processes, product line expansion, and product localization
• Representing the company's interests when interacting with regulatory authorities, as well as internal departments (marketing, R&D, quality, manufacturing)
• Monitoring changes in legislation and assessing their impact on the current product portfolio

Requirements

Successful Candidate Profile

• Higher education in biomedical engineering, biochemistry, biotechnology, pharmacy, medicine, or related natural science fields
• At least 5-7 years of experience in Regulatory Affairs in the fields of in vitro diagnostics (IVD), medical devices, or biotechnology.
• Fluent English

Requirements Not specified; Experience: 0 years

What we offer

Develop you will have access to a platform with workshops and lectures from colleagues in expert fields

This will help you

• extended VHI program including dentistry
• comfortable schedule and location: hybrid schedule 4/1 (1 day of working from home), flexible start and end times, modern office with convenient infrastructure 2 minutes walk from Voykovskaya metro / 5 minutes walk from Baltiyskaya MCC
• an open, supportive, and inclusive work environment where you are treated fairly and with respect

This will help you

• transparent bonus and KPI system
• annual salary review based on performance

Other

To fill the vacant position, we are announcing a competition for the Senior Registration Specialist position.