Regulatory Specialist 2

About This Opportunity

We are representing a confidential medical device organization seeking a Regulatory Specialist to join their growing team. This is a remote position based in the United States. Our client is looking for a subject matter expert in global medical device regulations who will play a critical role in regulatory strategy, compliance, and product development support.

As a key member of the regulatory team, you will ensure that medical device products meet stringent quality and safety standards across multiple global markets. You'll work cross-functionally with product development, quality, operations, and clinical teams to maintain regulatory compliance while supporting business growth.

Responsibilities

• Prepare and submit global regulatory applications for medical devices across multiple markets including MDSAP regions, EU, and UK
• Provide regulatory support to product development teams, including review and approval of design control documentation, risk management reports, clinical documentation, and technical protocols
• Assess product design, labeling, manufacturing, and quality system changes for regulatory impact and author change impact assessments
• Develop, review, and approve product labels, instructions for use, promotional materials, and product claims to ensure compliance with global regulatory requirements
• Monitor and assess changes to global medical device regulations, standards, and guidance requirements (regulatory intelligence)
• Serve as company representative with regulatory agencies and business partners, maintaining positive relationships through professional communications
• Support distributors and business partners in securing and maintaining regulatory clearances
• Lead and support corrective and preventive action activities related to quality system and product non-conformities
• Participate in internal and external audits
• Maintain tracking systems for current projects and future activity loads
• Develop and maintain departmental procedures, work instructions, and forms

What We're Looking For

Required Qualifications:

• Bachelor's degree in a scientific or technical discipline (regulatory, engineering, or biological science preferred) plus 3+ years of relevant regulatory experience, OR 5+ years of relevant experience in lieu of degree
• Strong understanding of medical device regulations including FDA Quality Management System Regulation (QMSR), MDD 93/42/EEC, MDR 2017/745, and ISO 13485
• Knowledge of product development, design controls, and risk management
• Understanding of medical terminology and quality systems
• Excellent written and verbal communication skills, including ability to deliver presentations
• Strong organizational skills and attention to detail
• Proficiency with computer systems and willingness to learn new technology tools
• Ability to work independently and collaboratively across cross-functional teams
• Project management skills with ability to monitor status and deliver accurate reporting

Preferred Qualifications:

• RAC (Regulatory Affairs Certification) certification

Key Competencies:

• Adaptability and openness to change
• Strong problem-solving and critical thinking abilities
• Results-driven with ability to meet deadlines under pressure
• High sense of urgency and productivity
• Ethical conduct with ability to maintain confidentiality
• Strategic thinking with creative approach to solutions
• Customer focus for both internal and external stakeholders

How We Work with You

Get A Job.ai serves as your advocate throughout the hiring process. Here's how it works:

• Submit your application directly through the Get A Job.ai platform
• Our experienced recruiters will screen your qualifications and conduct an initial interview
• We'll prepare and submit your profile to our client on your behalf
• We'll coordinate all interview scheduling and provide guidance throughout the process
• Please do not contact the client directly—all communication should flow through Get A Job.ai to ensure the best outcome

Pay

Compensation details will be discussed during the screening process with our recruiting team and will be commensurate with experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to providing equal employment opportunities to all applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or any other protected characteristic under applicable law.