Boston Scientific Regulatory Affairs Specialist 

Poland, Masovian Voivodeship, Warsaw 

236570087

Greece-Athens (Attica); Spain-Madrid

Key Responsibilities:

• Providing regulatory support to the Regulatory teams throughout EMEA (Europe Middle East and Africa) region and support of some cross-divisional activities.
• Assess product change notifications for impact to product registrations and notifications in the EMEA region.
• Registering and updating product data in Competent Authority databases
• Using, maintaining and developing digital and AI tools for information retrieval and database maintenance
• Maintaining the EMEA Regulatory database based on the information received from US Divisional Teams and from internal processes. Database contains regulatory information for all Boston Scientific Medical Devices.
• Tracking documentation changes via internal systems.
• Developing and maintaining a link for Divisional RA teams, communicating new products certifications and recertification’s.
• Establish and maintain a good working relationship with regional regulatory affairs, cross-functional peers and business units to gain positive & timely support.
• Supporting regulatory operations activities in conjunction with global regulatory operations.
• Suggest opportunities to add efficiencies to existing processes as part of department’s VIP goals.

Quality System Requirements

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Requirements:

• First experience in RA department
• Fluent written and spoken English
• 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

We offer:

• Work in an international environment with development opportunities
• Other benefits (depends on coutry specific)