Regulatory & Quality Specialist; Senior Level

We are seeking a Regulatory and Quality Specialist with experience collaborating with Quality, Sales/Marketing, and Research and Development teams to register and maintain medical devices where MID Labs products are marketed. The ideal candidate will have a strong regulatory knowledge throughout the product lifecycle, with aspects of effective management and regulatory strategies for product launches in global markets. This position supports the RA function by assisting with the coordination and preparation of global regulatory premarket and post-market submissions.

• Lead and support US and OUS product registration activities, along with developing regulatory strategy to achieve timely approvals and support business growth.
• Collect and analyze regulatory information/intelligence to assess changes in the regulatory landscape to ensure compliance with ISO, regulatory requirements, and the quality management system.
• Lead and support change impact assessments and initiate a change notification plan to external parties (Customers, Notified Body, and Regulatory Agencies) to ensure products meet all regulatory, customer, and company requirements.
• Work closely with R&D through the development of a regulatory strategy and objective to ensure adequate planning to bring new products to the market, as well as product sustainability and product end of life activities.
• Serve as a primary point of contact for global affiliates, customers, importers, and distributors of MID Labs marketed devices and OEM devices regarding registration activities.
• Obtain document notarization, capitalization, legalization, as needed.
• Identify regulatory risks for pre- and post-product launch and collaborate with stakeholders to develop effective mitigation strategies.
• Collaborate with R&D, Manufacturing, Marketing, and external consultants to support risk management, clinical evaluation, and labeling activities.
• Assist with environmental regulations and standards (i.e. RoHS, WEEE Directive, REACH, etc.)
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Author and lead regulatory documentation and submissions for U.S FDA 510(k), EU MDR Technical File/Documentation, internal Letters to File, registrations/licenses, and amendments, with minimal supervision.
• Collect, analyze, and trend post-market surveillance data throughout the lifecycle of the product and identify the need for corrective and preventive action.
• Support internal or external audits, including preparing responses to audit findings in support of regulatory clearance/approvals.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Maintain and archive company’s regulatory/notified body files, including regulatory submissions, deficiency letters, certificates/licenses, clearances/approvals, and all associated correspondence.
• Interpret domestic or international laws, guidelines, standards, regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents, including the Medical Device Directive (MDD), Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
• Conduct regulatory review and/or approve product labeling (IFU, graphic/symbols, UDI) and advertising/promotional materials (brochure) claims to ensure compliance with design outputs and applicable ISO/regulatory requirements.
• Served as the backup Person Responsible for Regulatory Compliance (PRRC) role mandated in Medical Device Regulations (MDR) EU 2017/745.
• All other duties as requested by his/her manager.

• 3+ years of Regulatory Affairs or Quality System experience in an FDA/EU-regulated environment with working knowledge of FDA 21 CFR part 820/QMSR, EN ISO 13485, and MDD and EU MDR for Class II medical device is required.
• Bachelor’s degree preferably in a scientific discipline such as Science, or…