Regulatory and Quality Specialist - Bertec : Job Details

Job Description

We are seeking a talented Regulatory and Quality Specialist to join our growing team. As a Regulatory and Quality Specialist, you will be responsible for new and existing registrations with various governmental regulatory bodies (FDA, EU/EMA, etc.), monitoring regulatory standards to track and ensure compliance, and assisting with internal and external audits when necessary. Additionally, you will help monitor, design, and implement quality processes and initiatives throughout the company. If you are detail-oriented, proactive, and passionate about regulatory compliance and quality assurance, this role could be a great fit for you.

Company Summary

Bertec is a leading provider of biomechanical testing and training solutions for researchers, clinicians, and athletes. Founded in 1987, Bertec has been at the forefront of the biomechanics industry, developing innovative technology and software that is used in universities, hospitals, sports teams, and research centers around the world.

Institutions as varied as Nike, the US Olympic Swimming Team, LA Dodgers, Golden State Warriors, Toyota Robotics, the NIH, Cleveland Clinic, Mayo Clinic, Harvard University, Stanford University, and thousands of others around the world rely on Bertec's tools to assess and analyze human movement, balance, and performance.

In addition to its product offerings, Bertec also provides training and support services to its customers. Its team of expert engineers and scientists work closely with customers to understand their unique needs and develop customized solutions to meet their specific requirements.

At Bertec, we are dedicated to advancing the field of biomechanics through innovation, collaboration, and a commitment to excellence. We are always looking for talented individuals who share our passion for improving human performance and wellbeing.

Department: Quality Assurance

Reports To: Quality Assurance Manager

Responsibilities

• Collaborate with private and governmental regulatory agencies to register Bertec products.
• Ensure timely renewal and maintenance of existing product registrations to comply with regulatory requirements.
• Stay updated on regulatory standards requirements relevant to Bertec products, monitor changes in regulations, and proactively implement necessary compliance measures.
• Work closely with teams within Bertec to integrate compliance considerations into the design and development process.
• Conduct periodic internal audits on the Bertec quality system to assess compliance with regulatory standards and identify areas for improvement.
• Assist in the preparation of audit reports and recommend corrective actions as needed.
• Support external audits conducted by regulatory agencies (FDA & EU/EMA) or third-party auditors. Ensure all necessary documentation and information are readily available during audits and assist in addressing any audit findings.
• Conduct and analyze post market surveillance of regulated products.
• Collaborate with internal and external subject matter experts (SMEs) to meet regulatory requirements for medical devices and clinical applications.
• Review, analyze, and make improvements to new and existing quality processes and procedures.
• Assist the Production, Product, and Engineering teams in integrating new products into our Quality System.
• Create and maintain quality documentation, including quality check sheets, work instructions, and Quality Operating Procedures.

Qualifications

• Bachelor's degree in a relevant technical field (engineering, business, etc.)
• Proven experience in regulatory affairs or a similar role within the medical device, healthcare, or manufacturing industries.
• In-depth knowledge of regulatory requirements associated with ISO and MDR standards. Experience with ISO13485 is preferred.
• Strong analytical and problem-solving skills with acute attention to detail.
• Willingness to learn, and keep up with, new technologies and regulatory standards.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.
• Exposure to internal and external audits is preferred.

Work Environment

Bertec allows a flexible work from home policy. New employees will typically work in-office as they are trained and brought up to speed on their job as well as Bertec products and policies. After that point, work from home varies based on job function and responsibilities. In-office work will mainly be performed at Bertec's offices in Columbus, OH.

Pay & Benefits

• Competitive salary based on skills and experience.
• Health, dental, and vision insurance
• 401(k) plan with 4% company match
• Paid time off and 13 paid holidays
• Training and professional development opportunities