Boston Scientific Sr Regulatory Affairs Specialist - Cardiac Diagnostics CDx 

United States, Minnesota, Arden Hills 

259511188

You’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer diagnostic and treatment solutions for treating irregular heart rhythms and heart failure. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.

Your responsibilities will include:

• Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
• Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
• Develops and maintains positive relationships with regulatory body reviewers
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Support regulatory audits, as required

Required qualifications:

• A minimum of a bachelor's degree or equivalent work experience
• A minimum of 5 years work experience in regulatory affairs or related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices, pharmaceutical, or health care industry
• Working knowledge of relevant US/EU and/or International regulatory requirements for medical devices including Quality Systems standards
• Effective written and oral communication, technical writing and editing skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• Bachelor's Degree in life sciences, engineering, computer science or related field
• Previous experience with Class II or III medical devices submissions
• Experience working directly with FDA, notified bodies and/or international health authorities
• Experience working with Medical Electrical Equipment (MEE) and related IEC 60601 standards
• Experience working with medical device software

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.