Regulatory Affairs Specialist

Description

The Regulatory Affairs Specialist is a key member of the Kerecis Product Development team with responsibilities that focus on pre-market regulatory activities. These include developing regulatory strategies, preparing and submitting FDA applications, and assembling regulatory dossiers. The Specialist collaborates with various internal teams and external consultants to execute development projects, drafting documents to meet regulatory requirements, reviewing testing protocols, and coordinating device clearance in different markets.

This full-time role is based on-site in a Kerecis office and reports to the Regulatory Affairs Manager with dotted-line reporting to the Director of Research and Product Development.

Essential Functions

• Support the development of regulatory mapping and strategies for new products and technology development
• Prepare and submit 510(k) and other applications to the FDA and collaborate directly with FDA reviewers to gain market approval
• Compile dossiers fit for the FDA (510k/PMA) and regulatory agencies of other jurisdictions
• Understand and adhere to the phase-gated product development processes to execute projects and tasks in collaboration with engineering, quality and clinical affairs teams
• Draft and revise documents that meet the MDR and ISO requirements 
• Work with external regulatory consultants when necessary to create documents that meet all necessary requirements
• Understand and review protocols for testing required for regulatory submissions in collaboration with the Product Development and Quality Assurance teams
• Support assigned medical device and consumer product development projects from initial kickoff to post-marketing phase and provide regulatory expertise as needed
• Stay current on the regulatory environment regarding medical products, and propose product design rules accordingly
• Other tasks and responsibilities as assigned

Requirements

Competencies & Attributes

• Demonstrated ability to work in product development and engineering teams for input/output analysis of the product and defining testing needs
• Proven ability to work with a risk-assessment team to manage risk analysis and evaluation of medical devices  
• Analytical aptitude and attention to detail
• Ability to solve problems and make sound data-driven decisions. Trouble-shooter with a strong bias for action
• Strong communication skills, written and spoken 
• Demonstrated ability to lead regulatory work in technically driven projects
• Enthusiasm for interacting with multidisciplinary colleagues in a team environment
• Talent for motivating and guiding others to meet objectives and drive actions to closure
• Innovative thinker, creative, willing to challenge established thinking
• Flexibility and adaptability in response to rapidly changing priorities
• Strong work ethic to deliver high-quality products on time and within budget
• Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint

Education & Experience

• Bachelor’s degree from an accredited college or university in Engineering or related field preferred
• 5+ years of experience in the Medical Device field is desirable
• 3+ years of experience in the Medical Device regulatory field supporting pre-market product development activities
• Previous experience in other product development roles in the Medical Device industry encouraged

Travel: 0-15% 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.