Regulatory Affairs Specialist I

Purpose Statement: 

This position is responsible for Regulatory Affairs support of on-going regulatory compliance throughout the product lifecycle. The successful candidate is expected to demonstrate their commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and understanding of the regulations governing the quality systems. The position is also responsible for ensuring continued compliance with regulatory agency approvals including supplier/design and process change impact assessments. Role will potentially require some International travel. Opportunities to work with teams based in EU and US.

Job Responsibilities: 

• Review and assessment of product and manufacturing changes for compliance with applicable regulations.
• Collaboration with international regulatory counterparts to provide deliverables and ensure compliance to local regulations when developing regulatory strategies and assessing changes.
• Support in Regulatory body audits, such as FDA, BSI, DEKRA.
• Liaise with both middle and senior management on any regulatory issues relating to their area.
• Maintain information in any internal regulatory databases.
• Support and maintain Quality initiatives in accordance with BSC Quality Policy.
• Continuously assess ways to improve Quality.
• Administrative support tasks (e.g., submission support).

Job Requirements:   

• Candidate require process at least Bachelor’s degree in a scientific, technical or related discipline.
• Minimum of one (1) year Regulatory Affairs or related experience at Medical Device industry.
• Has general knowledge of current and proposed US and EU regulations for medical devices.
• Familiar with ISO 13485 and MDSAP requirements.
• Ability to manage several projects simultaneously with keen attention to detail.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to work independently with minimal supervision.
• General knowledge of product development process and design control.
• Proficiency in the use of computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat.
• Effective written, oral communication, technical writing and editing skills.
• Effective research and analytical skills.
• Team player with good interpersonal skills.

About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.