Regulatory Affairs Specialist

Job Description

Job Description

Description:

The Regulatory Specialist is part of the Regulatory team and reports directly to the VP of Regulatory Affairs and Quality Assurance. This is a full-time position based in a Kerecis office.

Essential Functions

• Prepare and submit 510(k) and applications to the FDA and collaborate directly with FDA reviewers to gain marketing approval.
• Assemble and write regulatory dossiers fit for the FDA (510k/PMA) and other jurisdictions.
• Understand and use the Kerecis-gated development process to execute development projects and tasks.
• Apply for certification, manage country licenses, and manage communications with country authorities.
• Drafting documents that meet the MDR and ISO requirements.
• Working with external consultants when necessary to create documents that meet all necessary requirements.
• Understand and review clinical protocols for testing required for regulatory submissions.
• Support and provide regulatory expertise to assigned medical device and consumer product development projects from initial kickoff to post-marketing phase.
• Coordinate with Kerecis domestic and international business units for device clearance in intended markets.
• Have knowledge of, and stay current on, the legal environment regarding medical products, and create product design rules accordingly.

Competencies

• Works with cross functional teams to complete assigned tasks.
• Work in teams for input/output analysis of the product and define testing needs.
• Work with the risk-assessment team to manage risk analysis and evaluation of medical devices.
• Skill and ability to think analytically by solving problems to make decisions.
• Strong communication skills and attention to detail
• Self-motivated problem-solver / trouble-shooter with a strong bias for action
• Demonstrated ability to lead technically driven projects
• Ability to interact with multidisciplinary colleagues in a team environment
• Ability to motivate and guide 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
• Ability to collaborate in a cross-functional and external environment
• Comfortable coordinating with vendors by phone and email
• Strong work ethic to deliver high-quality products on time and within budget
• Proficient organizational, record keeping and communication skills (oral and written), with excellent presentation technique
• Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint

Education & Experience:

• 3+ years of Medical Device regulatory experience is desirable.
• A degree in Engineering field is preferred.

Travel: 0-5%

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.