Regulatory Affairs Specialist
Regulatory Affairs Specialist
Boston Scientific
Warsaw, Poland
Key responsibilities:
- 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.
Requirements:
- 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.
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