Regulatory Specialist – Level 2
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Job Description
Regulatory Specialist guiding global medical-device submissions, labeling, and quality-system compliance. Supporting product teams, audits, corrective actions, and regulatory agency relationships.
Responsibilities:
- 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
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