Regulatory Specialist – Level 2

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EXALTA Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🎖️ Defense

Healthcare • Consulting • Defense

EXALTA Group is an integrated MedTech OEM that co-develops, engineers, and manufactures orthopedic and adjacent medical devices from concept through regulatory clearance to market launch. The company offers turnkey device development, regulatory support (510(k) and EU MDR), precision machining, forging, finishing, and post-market surveillance across spine, trauma, extremities, reconstruction, and enabling technologies like surgical robotics and navigation. EXALTA emphasizes speed-to-market, global manufacturing scale with nearshoring options, validated QMS infrastructure, and supply-chain resilience for OEM partners.

📋 Description

• Provide regulatory support to product development and business teams • Prepare regulatory opinion documents and coordinate labeling activities • Review and approve design control documentation, risk management reports, technical protocols/reports, clinical documentation, and other product-development outputs • Prepare, write, submit, and manage global regulatory applications, including MDSAP markets, the EU, and the UK • Maintain internal regulatory file documentation • Support distributors and business partners in securing and maintaining regulatory clearances • Track current projects and forecast future activity loads • Develop and maintain relationships with global regulatory agencies and business partners • Collaborate cross-functionally with research and development, operations, quality, microbiology, packaging, medical affairs, and clinical affairs • Assess product design, labeling, quality system, manufacturing, and material changes for regulatory impact • Author responses to proposed standards, directives, policies, and legislation • Develop, process, and maintain departmental procedures, work instructions, and forms; facilitate training • Support the design, development, review, and approval of product labels, advertising/promotional materials, product claims, and instructions for use • Monitor and assess changes to global regulations, directives, standards, and guidance requirements • Manage project teams to complete compliance activities • Support regulatory aspects of the quality system and product non-conformities • Lead assigned corrective and preventive action activities • Participate in internal audits and external audits

🎯 Requirements

• Bachelor’s degree in a scientific or technical discipline, preferably regulatory, engineering, or biological science • Minimum 3 years of relevant experience • 5 or more years of relevant experience may substitute for the degree • RAC certification(s) a plus • Strong understanding of product development, design controls, and risk management • Strong understanding of medical terminology and medical-device and quality-system regulations and guidelines • Knowledge of FDA Quality Management System Regulation (QMSR), MDD 93/42/EEC, MDR 2017/745, and ISO 13485 • Computer proficiency and ability to learn new technology and tools quickly • Project management knowledge and ability to monitor project status and deliver accurate status reporting • Proficient written and verbal communication and presentation skills • High attention to detail, problem-solving, decision-making, organization, and time-management skills • Ability to work independently and cross-functionally • Ability to handle objects up to 20 lbs. occasionally • Ability to sit for 8 hours per day and stand for 1 hour per day • Ability to perform repetitive tasks/motions, with good manual dexterity and eye/hand/foot coordination • Ability to hear alarms, telephone, and normal speaking volume; clarity of vision • Ability to work in a manufacturing environment with potential exposure to listed hazards

🏖️ Benefits

• Remote work • Personal protective equipment provided/required for applicable tasks, including scrubs, gloves, masks, safety glasses, and safety shoes