Senior Regulatory Affairs Specialist

Trividia Health, Inc. • Fort Lauderdale, FL

9h • Hybrid

About The Position

Supports domestic and international regulatory affairs activities associated with medical device and IVD product lifecycle management, global regulatory compliance, and post-market regulatory activities. Responsibilities include support of domestic and international product registrations, labeling and change assessments, complaint and recall support activities, regulatory remediation efforts, and participation in cross-functional regulatory and quality initiatives. This position will also support selected pre-market regulatory activities including FDA submissions, clinical support activities, and regulatory strategy initiatives as business needs require and offers exposure to multiple aspects of global regulatory affairs across the product lifecycle.

Requirements

• Bachelor of Science degree (B.S.) in a health, life sciences, engineering, or related discipline from a four-year college or university
• 5+ years of regulatory affairs experience within the medical device and/or IVD industry.
• Strong technical writing and communication skills required.
• Ability to interpret governmental regulations, technical procedures, and scientific information.
• Mastery of the English language in written form is required.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Nice To Haves

• Experience supporting post-market regulatory compliance activities including complaint investigations, recalls, field actions, CAPA support, change management, and regulatory remediation activities is strongly preferred.
• Exposure to or experience supporting FDA pre-submissions, Special 510(k), Traditional 510(k), De Novo submissions, clinical trial support, IDE submissions, and regulatory strategy development is desirable.
• Experience with Microsoft Office and electronic document management systems preferred.
• RAC certification preferred but not required.
• Experience with international regulatory submissions preferred.

Responsibilities

• Support domestic and international regulatory compliance activities associated with marketed medical device and IVD products.
• Support product lifecycle management activities including change assessments, labeling updates, regulatory impact assessments, and global registrations.
• Assist with post-market regulatory activities including complaint assessments, recalls, field actions, CAPA support, and regulatory remediation activities.
• Participate in cross-functional activities associated with product quality, compliance, and regulatory risk management.
• Review technical documentation, labeling, promotional materials, and product claims for regulatory compliance.
• Support communication and interaction with regulatory authorities, notified bodies, and external regulatory partners as required.
• Conduct regulatory intelligence searches and monitor changes to domestic and international regulations, guidance documents, and standards.
• Generate and revise quality system procedures, work instructions, and regulatory processes in accordance with current regulatory requirements.
• Participate in regulatory and quality system inspections and audits as needed.
• Support development and execution of regulatory strategies to meet business and product development goals.
• Provide support for selected pre-market regulatory activities including FDA pre-submissions, Special 510(k), Traditional 510(k), De Novo, IDE, and international regulatory submissions as applicable.
• Support Human factors, clinical, and regulatory activities associated with clinical studies and product evaluations as required.
• Coordinate regulatory activities with external consultants and cross-functional internal teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior