Principal Regulatory Affairs Specialist

Meridian Bioscience, Inc.•Billerica, MA

3d•$145,000 - $185,000

About The Position

The Principal Regulatory Affairs Specialist is a senior technical leader and regulatory subject matter expert responsible for developing and executing 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 collaborates with cross-functional stakeholders to help ensure products remain compliant with applicable regulatory requirements and supports product lifecycle management, market expansion, risk management, and regulatory excellence. The role provides regulatory leadership for assigned products and product families; oversees global submissions and technical documentation; and advises teams on regulatory pathways, agency interactions, and the impact of changing requirements. The position also provides regulatory oversight for complaint handling, adverse event reporting, post-market surveillance, risk assessments, recalls, labeling, promotional materials, audits, and compliance initiatives. As a recognized subject matter expert, the specialist mentors Regulatory Affairs professionals, guides cross-functional teams, leads critical projects, and represents the organization during regulatory audits, inspections, and external interactions.

Requirements

Bachelor of Science degree in Biology, Biochemistry, Microbiology, or a related field.
At least 10 years of direct Regulatory Affairs experience, including preparation of 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 medical device design, development, and clearance.
Understanding of regulatory compliance obligations within the department's scope, including 21 CFR 820, 803, and 806 and ISO 13485.
Understanding and 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, judge priorities, adapt to shifting priorities, work with minimal supervision, and resolve problems or conflicts independently.
Ability to make decisions quickly using available information and determine when clarification or direction is needed.
Inquisitive and problem-solving mindset.
Exceptional organizational and time-management skills.
Strong interpersonal skills and ability to lead teams and facilitate team meetings.
Effective verbal communication and technical writing skills.
Computer skills, including MS Office, Outlook, and Excel.
Willingness to travel 10%.

Nice To Haves

Advanced degree.
Regulatory Affairs Certification.

Responsibilities

Serve as the regulatory lead for assigned products and product families throughout the product lifecycle.
Develop and execute regulatory strategies for global product registrations, renewals, market expansion, and lifecycle management.
Evaluate regulatory impacts of product, software, manufacturing, labeling, supplier, and process changes; recommend 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.
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 regulatory approvals.
Support FDA submissions, European Union MDR compliance, Health Canada licensing, and international regulatory registrations.
Provide strategic guidance on regulatory submission content, timelines, and agency interactions.
Oversee complaint handling, post-market surveillance, adverse event reporting, and vigilance activities.
Review 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, adverse event reports, and vigilance reports in accordance with global requirements.
Provide regulatory expertise for investigations involving product performance, safety concerns, and compliance issues.
Lead post-market risk assessments and health hazard evaluations related to 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, operator and service manuals, package inserts, and related documentation.
Ensure labeling and customer-facing documentation comply with 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.
Review complaint investigations, trend analyses, corrective action recommendations, and post-market surveillance outputs for regulatory compliance.
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 enhance regulatory compliance, post-market surveillance processes, and regulatory intelligence activities.
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 expert interpretation of regulatory requirements and risk-based recommendations.
Lead critical cross-functional projects involving product compliance, regulatory strategy, and market expansion.
Maintain advanced knowledge of FDA regulations, EU MDR, ISO 13485, Health Canada regulations, and other applicable international requirements.
Represent the organization during regulatory audits, inspections, and external regulatory interactions as required.
Perform other duties and special projects as assigned.