Principal Regulatory Affairs Specialist

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Principal Regulatory Affairs Specialist serves as a senior technical leader and regulatory subject matter expert responsible for developing and executing global regulatory strategies throughout the product lifecycle. This role provides strategic oversight for regulatory compliance, post-market surveillance, product vigilance activities, product change assessments, global registrations, and field actions.

 

The Principal Regulatory Affairs Specialist collaborates with cross-functional stakeholders to ensure products remain compliant with applicable regulatory requirements and supports organizational objectives related to product lifecycle management, market expansion, risk management, and regulatory excellence.

Key Duties

Regulatory Strategy & Product Lifecycle Management

• Serve as the regulatory lead for assigned products and product families throughout the entire product lifecycle.
• Develop and execute regulatory strategies supporting global product registrations, renewals, market expansion initiatives, and lifecycle management activities.
• Evaluate the regulatory impact of product, software, manufacturing, labeling, supplier, and process changes and provide recommendations regarding submission requirements and regulatory pathways.
• Provide regulatory leadership and guidance to cross-functional teams including R&D, Manufacturing, Quality, Marketing, Clinical Affairs, and Commercial Operations.
• Monitor evolving global regulatory requirements and assess business impacts, compliance risks, and implementation strategies.

Regulatory Submissions & Technical Documentation

• Lead the preparation, review, approval, and maintenance of technical documentation required for global regulatory submissions.
• Oversee maintenance of technical files, Design History Files (DHF), regulatory dossiers, and product documentation supporting regulatory approvals.
• Support FDA submissions, European Union MDR compliance activities, Health Canada licensing activities, and international regulatory registrations.
• Compile and maintain technical documentation supporting product registrations, market expansions, and regulatory commitments worldwide.
• Provide strategic guidance regarding regulatory submission content, timelines, and agency interactions.

Post-Market Surveillance & Vigilance

• Provide regulatory oversight for complaint handling, post-market surveillance, adverse event reporting, and vigilance activities.
• Review and assess escalated product complaints, adverse events, and product quality issues for regulatory significance and reporting obligations.
• Evaluate complaint and post-market surveillance trends to identify emerging safety, quality, or compliance risks.
• Ensure timely and accurate submission of Medical Device Reports (MDRs), adverse event reports, and vigilance reports in accordance with global regulatory requirements

• Provide regulatory expertise for investigations involving product performance, safety concerns, and compliance issues.

Risk Management & Field Actions

• Lead post-market risk assessments and health hazard evaluations associated with product quality and safety concerns.
• Assess regulatory reporting requirements related to corrections, removals, field safety corrective actions, and recalls.
• Provide regulatory leadership during field actions and recalls, including communications with regulatory authorities and internal stakeholders.
• Ensure post-market findings are appropriately incorporated into product risk management documentation and risk assessments.

Labeling & Promotional Compliance

• Review and approve product labeling, Instructions for Use (IFUs), operator manuals, service manuals, package inserts, and related documentation.
• Ensure labeling and customer-facing documentation remain compliant with applicable regulatory requirements and approved product claims.
• Review and provide regulatory approval for promotional materials, marketing collateral, website content, and product communications.
• Partner with Commercial and Marketing teams to ensure advertising and promotional activities comply with applicable regulations.

Quality & Compliance Leadership

• Review complaint investigations, trend analyses, corrective action recommendations, and post-market surveillance outputs to ensure regulatory compliance.
• Analyze manufacturing and Device History Records (DHRs) as necessary to support investigations and regulatory assessments.
• Support regulatory inspections, internal audits, Notified Body audits, customer audits, and agency inquiries.
• Lead initiatives to enhance regulatory compliance, post-market surveillance processes, and regulatory intelligence activities.
• Develop and deliver training related to regulatory requirements, post-market obligations, and product lifecycle compliance.

Technical Leadership

• Serve as a recognized subject matter expert in Regulatory Affairs and post-market compliance.
• Mentor and provide technical guidance to Regulatory Affairs professionals and cross-functional teams.
• Influence organizational decision-making through expert interpretation of regulatory requirements and risk-based recommendations.
• Lead critical cross-functional projects involving product compliance, regulatory strategy, and market expansion activities.

Other Responsibilities

• Maintain advanced knowledge of FDA regulations, EU MDR, ISO 13485, Health Canada regulations, and other applicable international regulatory requirements.
• Represent the organization during regulatory audits, inspections, and external regulatory interactions as required.
• Perform other duties and special projects as assigned

Qualifications

• Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
• Advance degree and/or Regulatory Affairs Certification preferred
• A minimum of 10 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.
• Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971).
• Experience with design, development, and clearance of medical devices.
• Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820, 803, 806; ISO 13485).
• Solid understanding and experience with CE marking, technical files and product registration requirements (domestic and international)
• Strong knowledge of post market regulatory compliance requirements
• Reasoning ability, support and prioritize projects – appropriately judging priorities, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts independently.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
• Inquisitive and problem-solving mindset.
• Exceptional organizational skills, including time management.
• Strong interpersonal skills: ability to lead teams and facilitate team meetings.
• Effective communication skills, including verbal and technical writing skills.
• Knowledge based computer skills, such as MS office, outlook and excel
• Travel: 10%

Compensation Range: $145,000–$185,000