Job Summary

The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products. This role involves collaborating with cross-functional teams to ensure compliance with applicable regulations and standards while facilitating product commercialization and market access.

This position is responsible for providing support for assigned biological evaluation projects for both internal and external customers. The Senior Regulatory Affairs Specialist will provide support to the functional project teams on Biological Evaluations for new and existing products/indications. The role will involve implementing biological evaluation plans and reports to meet business targets, participating and interacting with project groups ensuring MDD/MDR Compliance, assisting with pre-clinical and clinical submissions and departmental projects as assigned.

Role and Responsibilities

• Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
• Respond to requests from notified bodies; competent authorities and/ or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Provide regulatory direction to development project teams as a core team member.
• Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
• Review proposed labeling/instructions for use for compliance with applicable local and international regulations.
• Recommends changes for labeling and internal documentation, reports for regulatory compliance.
• Keeps abreast of regulatory procedures and changes. Support review of internal procedures to ensure continuous compliance with all regulatory requirements.
• May have direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Co-ordinate gap assessments between against regulatory requirements.
• Communicates status of projects / submissions directly to senior management as required.

Biological Evaluation Specific

• Supports/prepares biological evaluation plans and reports for marketing, regulatory affairs, clinical affairs design review, post market surveillance and reimbursement purposes.
• Become the Subject Matter Expert (SME) for PBC Biomed’s Biological safety process.
• Coordinates multiple projects at one time and provides regular reports to regulatory management, clinical affairs and others as required.
• Works closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.
• Maintains an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within PBC Biomed’s Biological safety processes.
• Coordination with external biological laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes, critical review of protocols, reports, etc.
• Communication with consultant / toxicologists / peer review within PBC Biomed as necessary
• Design and conduct literature searches on products, specific surgical indications, outcomes or other areas.
• A primary contact for biological working groups / training going forward.
• Supports pre-clinical and clinical activities as required.

Risk Management

• Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.
• Develop and oversee biocompatibility testing strategies, including material characterization, in vitro, and in vivo studies.
• Ensure alignment with global regulatory standards (FDA, EU MDR, ISO 14971) and support risk management file development.
• Work closely with R&D, Quality, and Regulatory teams to mitigate biological risks and support product development and submissions.

Qualifications and Education Requirements

• Level 8 Honor’s Degree Science or Engineering bachelor’s degree/master’s with a minimum of 3-5 years relevant experience with medical devices.
• Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
• Understanding of applicable guidelines and regulations, for example experience with ISO 10993
• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.

Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.