Job Description

About the Company - Our client has an exciting opportunity to join their team which has averaged 96% retention over the past decade. This Principal Regulatory Affairs Specialist role will lead regulatory strategy, compliance, and submission strategies around AI, ML, and cybersecurity for their PCI guidance system and IVUS catheter technology. Our global Medtech partner is investing in portfolio development and global execution as we expand the System capabilities.

About the Role - Your responsibilities will include:

• Represents RA on cross-functional projects including product development, manufacturing process changes, site transfers, and continuous improvement efforts
• Develops domestic and international strategies for regulatory approval of Class II and III electronic medical equipment devices
• Coordinates, compiles, and submits US and EU regulatory filings for new and modified products, including pre-submissions, 510(k)s, and CE Mark submissions under MDR
• Supports international regulatory partners with investigational device and commercial marketing applications
• Review of product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Develops and maintains positive relationships with regulatory agency staff
• Lead and/or participate in regulatory audits, as required

Qualifications - Required Qualifications:

• Minimum of a Bachelor's Degree
• Minimum of 7 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Master’s or PhD)
• 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 experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
• Strong technical, research and problem-solving skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred Skills - Preferred Qualifications:

• Bachelor's Degree in life sciences, engineering, or related field
• Previous experience in the medical device industry with Class II device submissions
• Experience working directly with FDA, notified bodies and/or international health authorities
• Prior experience with electrophysiology and/or medical electronic equipment products
• Able to work independently with minimal supervision
• Demonstrated leadership, strategic thinking, project planning, and project management skills

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