Regulatory Affairs Specialist

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Boston Scientific

Plan and prioritize product notification/registration for his/her respective countries (EU and non-EU);
Prepare and submit regulatory applications to local health authorities and/or distributors;
Maintain active knowledge of product approval status and shepherd registrations throughout the approval process. Provide management team with regular updates on product registration;
Ensure product registrations are reviewed and renewed as required;
Ensure documentation used, questions and answers from authorities and approvals are appropriately filed;
Be the first contact point for local authorities for regulatory queries;
Establish and maintain a good working relationship with regional and divisional RA peers to gain positive and timely support for submission preparation;
Establish and maintain a trusted relationship with local health authorities and/or distributors through regular meetings, discussions, and/or trainings;
Establish relationships with local medical device industry groups and work with industry peers to influence local policies;
Serve as a regulatory consultant to marketing teams;
Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal Quality system and policy.

Self-starter with 2 years’ experience in RA department;
Fluent written and spoken English (knowledge of Romanian would be an advantage);
Applicable regulatory certification required by NAMMDR would be an advantage;
Ability to manage multiple projects and data and strong attention to detail;
Ability to communicate effectively to all levels of organization and distributors/consultants;
Very good knowledge of MS Office;
Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field.

Don't forget to mention EuroPharmaJobs when applying.

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