Regulatory Affairs Specialist

The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices. This role provides support to currently-marketed products, involves evaluating proposed product and process changes, assessing documentation and providing guidance to ensure regulatory compliance. The Regulatory Affairs Specialist will work collaboratively with internal stakeholders.

From preparing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional. The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate. 1 Regulatory strategy • Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle. 2 Regulatory assessments • Review product and process changes and conduct regulatory assessments, ensuring the appropriate regulatory strategies are communicated to internal stakeholders. • Conduct risk assessments and provide recommendations to mitigate regulatory risks. 3 Regulatory submissions • Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices. 4 Regulatory compliance • Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP). 5 Regulatory interface and communication • Respond to regulatory agencies and coordinate responses with subject matter experts. • Ensure internal stakeholders are apprised of inquiries from health authorities during the submission approval process according to departmental communication cascades. 6 Cross-functional collaboration • Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle. 7 Document management • Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.
Essential Skills - Lead Self:

• Attention to Detail
• Analytical Skills
• Time Management
• Digital Acumen
• Problem Solving
• Emotional Intelligence
• Resiliency
• Communication Leadership
• Collaboration
• Project Management
• Motivate & Influence

Essential Skills - Lead Others:

• Leadership
• Collaboration
• Project Management
• Motivate & Influence

Technical & Functional Skills • Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 814, 21 CFR 820.
• Strong analytical, investigative, and organizational skills. Demonstrate curiosity preferred.
• Ability to work under pressure, prioritize, and handle multiple tasks.
• Self-starter with results-oriented mindset.
• Excellent written and verbal communications skills.
Minimum Qualifications • University degree; scientific discipline preferred, or the required years of direct experience.
• 4+ years’ experience in medical device industry
• 2+ years’ direct experience in medical device regulatory affairs, preferably with FDA class III devices.
• Knowledge of Quality Management System standards, including ISO 13485 and ISO 9001.
• Proficiency in MS Office (Excel, PowerPoint and Word)
Preferred Qualifications • Prior experience with PMA Class III devices
• Strong communication skills
• Ability to quickly adapt to changes in fast-paced environment
Physical Requirements
This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Pay Rate Range: $35-50/hr depending on experience