Senior Regulatory Affairs Lead

Meridian Bioscience Inc.; North Billerica (MA); On-site; USD 102,000 - 132,000; Full time

Job summary

Meridian Bioscience Inc. is seeking a Regulatory Affairs professional to support released products, manage MDR investigations, post market risk assessments, and maintain technical files for CE marking.

The role liaises with QA, manufacturing, R&D, and customers to coordinate complaint investigations and CAPAs. Responsibilities include updating technical files for FDA and EU submissions, evaluating regulatory impact of design changes, and guiding labeling activities to ensure compliance.

Qualifications

• Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
• A minimum of 4 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).
• 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.

Responsibilities

• Update and maintain technical files required for product approvals, including FDA submission documents, technical documentation for European Union and supporting regulatory submissions world-wide.
• Evaluates the regulatory impact of changes associated with product design change and routine change control of instruments and software.
• Work independently and/or cross functionally with various departments (e.g. sales, marketing, customer service, R&D, manufacturing)
• Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
• Receive, review and conduct investigations of escalated product complaints or assigned product quality issues, from data collection to investigation summary, including coordinating implementation or recommendation of follow-on quality system activities.
• Drafts, reviews, and helps provide guidance for product labeling activities, including package inserts, operator and/or service manuals, to ensure adherence to applicable regulations and standards.
• Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
• Compiles new product technical information and feature summaries in support of market expansion.
• Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actions/recalls related to complaints.
• Responds to Sales & Marketing requests to ensure content of collateral and promotional materials are compliant with applicable regulations.
• Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process.
• Lead post market risk assessment process and elevate critical issues for field action determination. Facilitate and manage the recall process when necessary.
• Provide support to R&D in the ongoing maintenance of product technical files that support US and international regulatory submissions.
• Review and analyze lot documentation (DHRs) to determine if there are any anomalies that may be related to reported product failures.
• Other duties as assigned.

Skills

Regulatory affairs

FDA knowledge

Risk management

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

BS in Biology or related field

Tools

MS Office

Excel

Job description

Meridian Bioscience Inc. is seeking a Regulatory Affairs professional to support released products, manage MDR investigations, post market risk assessments, and maintain technical files for CE marking.

The role liaises with QA, manufacturing, R&D, and customers to coordinate complaint investigations and CAPAs. Responsibilities include updating technical files for FDA and EU submissions, evaluating regulatory impact of design changes, and guiding labeling activities to ensure compliance.