Regulatory Specialist – Level 2

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer regulatory assistance to product development and business units.

• Create regulatory opinion documents and oversee labeling processes.

• Evaluate and authorize design control documents, risk management reports, technical protocols/reports, clinical documentation, and other outputs related to product development.

• Prepare, author, submit, and manage global regulatory applications, including MDSAP markets, the EU, and the UK.

• Keep internal regulatory file documentation up to date.

• Aid distributors and business partners in obtaining and sustaining regulatory approvals.

• Monitor current projects and anticipate future workload demands.

• Build and maintain relationships with global regulatory authorities and business partners.

• Collaborate across functions with research and development, operations, quality, microbiology, packaging, medical affairs, and clinical affairs.

• Evaluate product design, labeling, quality systems, manufacturing, and material changes for their regulatory implications.

• Draft responses to proposed standards, directives, policies, and legislation.

• Develop, implement, and maintain departmental procedures, work instructions, and forms; facilitate training as needed.

• Support the design, development, review, and approval of product labels, advertising/promotional materials, product claims, and instructions for use.

• Monitor and evaluate changes in global regulations, directives, standards, and guidance requirements.

• Lead project teams to accomplish compliance tasks.

• Assist with regulatory aspects of the quality system and product non-conformities.

• Spearhead assigned corrective and preventive action initiatives.

• Engage in internal and external audits.

⛳️ Requirements

• Bachelor’s degree in a scientific or technical field, ideally in regulatory affairs, engineering, or biological science.

• At least 3 years of pertinent experience.

• 5 or more years of relevant experience may replace the educational requirement.

• RAC certification(s) is advantageous.

• Comprehensive understanding of product development, design controls, and risk management.

• Strong grasp of medical terminology as well as medical device and quality system regulations and guidelines.

• Familiarity with FDA Quality Management System Regulation (QMSR), MDD 93/42/EEC, MDR 2017/745, and ISO 13485.

• Proficient in computer skills and capable of quickly learning new technologies and tools.

• Knowledge of project management and the ability to track project status while providing accurate status updates.

• Excellent written and verbal communication, along with presentation skills.

• High attention to detail, strong problem-solving, decision-making, organizational, and time-management abilities.

• Capable of working independently as well as collaboratively across functions.

• Ability to occasionally lift objects weighing up to 20 lbs.

• Capable of sitting for 8 hours a day and standing for 1 hour a day.

• Ability to perform repetitive tasks/motions, demonstrating good manual dexterity and eye/hand/foot coordination.

• Ability to hear alarms, telephones, and normal speech; clear vision is required.

• Willingness to work in a manufacturing setting with potential exposure to specified hazards.

🏝️ Benefits

• Remote work opportunities.

• Personal protective equipment provided or required for relevant tasks, including scrubs, gloves, masks, safety glasses, and safety shoes.