Principal Regulatory Affairs Specialist

Meridian Bioscience•North Billerica, MA

About The Position

The Principal Regulatory Affairs Specialist is a senior technical leader and regulatory subject matter expert who develops and executes global regulatory strategies throughout the product lifecycle. The role provides strategic oversight for regulatory compliance, post-market surveillance, product vigilance, product change assessments, global registrations, and field actions. The specialist partners with cross-functional stakeholders to keep products compliant with applicable requirements and support product lifecycle management, market expansion, risk management, and regulatory excellence. The role leads regulatory strategy for assigned products and product families, oversees global submissions and technical documentation, and advises teams on regulatory impacts of product, software, manufacturing, labeling, supplier, and process changes. It provides regulatory oversight for complaint handling, adverse event reporting, post-market trends, risk assessments, recalls, and other field actions. The specialist also reviews labeling and promotional materials, supports audits and inspections, improves compliance processes, delivers training, mentors colleagues, and leads critical cross-functional projects. The position requires a bachelor’s degree in Biology, Biochemistry, Microbiology, or a related field and at least 10 years of direct Regulatory Affairs experience. An advanced degree and/or Regulatory Affairs Certification is preferred. The role requires expertise in FDA and ISO-regulated environments, medical device and IVD requirements, global registrations, post-market compliance, and risk management. Travel is 10%. Compensation range: $145,000–$185,000.

Requirements

Bachelor of Science degree in Biology, Biochemistry, Microbiology, or a related field.
At least 10 years of direct Regulatory Affairs experience.
Experience preparing Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, and STED documentation.
Proven knowledge of FDA- and ISO-regulated environments, including medical devices, pharmaceuticals, and in vitro diagnostic medical devices.
Knowledge of risk management principles, such as ISO 14971.
Experience with the design, development, and clearance of medical devices.
Understanding of applicable regulatory obligations, including 21 CFR 820, 803, and 806, and ISO 13485.
Experience with CE marking, technical files, and domestic and international product registration requirements.
Strong knowledge of post-market regulatory compliance requirements.
Ability to reason, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, and resolve problems or conflicts independently.
Ability to make timely decisions using available information and determine when clarification or direction is needed.
Inquisitive, problem-solving mindset.
Exceptional organizational and time-management skills.
Strong interpersonal skills and ability to lead teams and facilitate meetings.
Effective verbal communication and technical writing skills.
Computer skills, including knowledge of Microsoft Office, Outlook, and Excel.

Nice To Haves

An advanced degree.
Regulatory Affairs Certification.

Responsibilities

Serve as regulatory lead for assigned products and product families throughout their lifecycle.
Develop and execute regulatory strategies for global registrations, renewals, market expansion, and lifecycle management.
Assess regulatory impacts of product, software, manufacturing, labeling, supplier, and process changes, and recommend submission requirements and pathways.
Provide regulatory leadership and guidance to cross-functional teams.
Monitor evolving global regulatory requirements and assess business impacts, compliance risks, and implementation strategies.
Lead preparation, review, approval, and maintenance of technical documentation for global regulatory submissions.
Oversee technical files, Design History Files, regulatory dossiers, and product documentation supporting approvals.
Support FDA submissions, EU MDR compliance, Health Canada licensing, and international registrations.
Provide strategic guidance on submission content, timelines, and agency interactions.
Oversee complaint handling, post-market surveillance, adverse event reporting, and vigilance activities.
Assess escalated complaints, adverse events, and product quality issues for regulatory significance and reporting obligations.
Evaluate complaint and post-market surveillance trends for emerging safety, quality, or compliance risks.
Ensure timely and accurate submission of Medical Device Reports, adverse event reports, and vigilance reports.
Provide regulatory expertise for investigations involving product performance, safety, and compliance.
Lead post-market risk assessments and health hazard evaluations associated with product quality and safety concerns.
Assess reporting requirements for corrections, removals, field safety corrective actions, and recalls.
Provide regulatory leadership during field actions and recalls, including communications with authorities and internal stakeholders.
Ensure post-market findings are incorporated into product risk management documentation and assessments.
Review and approve product labeling, instructions for use, manuals, package inserts, and related documentation.
Ensure labeling and customer-facing documentation comply with requirements and approved product claims.
Review and approve promotional materials, marketing collateral, website content, and product communications.
Partner with Commercial and Marketing teams to ensure advertising and promotional compliance.
Review complaint investigations, trend analyses, corrective action recommendations, and post-market surveillance outputs.
Analyze manufacturing and Device History Records as needed to support investigations and regulatory assessments.
Support regulatory inspections, internal audits, Notified Body audits, customer audits, and agency inquiries.
Lead initiatives to improve regulatory compliance, post-market surveillance processes, and regulatory intelligence.
Develop and deliver training on regulatory requirements, post-market obligations, and product lifecycle compliance.
Mentor and provide technical guidance to Regulatory Affairs professionals and cross-functional teams.
Influence organizational decisions through interpretation of regulatory requirements and risk-based recommendations.
Lead cross-functional projects involving product compliance, regulatory strategy, and market expansion.
Maintain advanced knowledge of applicable FDA, EU MDR, ISO 13485, Health Canada, and other international requirements.
Represent the organization during audits, inspections, and external regulatory interactions.
Perform other duties and special projects as assigned.