Principal Reg Affairs Specialist - Rhythm Management

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Principal Reg Affairs Specialist – Rhythm Management

 

About the role:

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

 

Under minimal supervision, the Principal Regulatory Affairs Specialist is responsible for developing regulatory strategy, planning, managing, and implementing regulatory approvals in the US and EU, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.

 

Your responsibilities will include:

• Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Researches and advises company on country specific international product registration and compliance related requirements
• 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
• Develops and maintains positive relationships with regulatory agency staff
• 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, site transfers, and continuous improvement efforts
• Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
• Review and approval of marketing materials
• Lead and/or participate in regulatory audits, as required

 

What we’re looking for in you:

Minimum qualifications:

• Bachelor's Degree
• 8+ years regulatory affairs experience in medical device or related industry
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
• Demonstrated leadership, strategic thinking, project planning, and project management skills
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