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Form of workJob Description
POSITION SUMMARY
An individual contributor who serves as a primary regulatory representative and Subject Matter Expert (SME) within the functional group, providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, EU MDD/MDR, ISO standards, and other regulatory requirements. Provide support for the regulatory department, including submission support and maintenance of existing product related files/reports, to ensure that deadlines are met.
ESSENTIAL FUNCTIONS OF THE POSITION
• Represent the regulatory function on product development teams to provide guidance and direction, inclusive of potential risks, to the cross-functional team; identify risk-based solutions and strategies for problem solving.
• Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packing, manufacturing process and facility.
• Review and approve protocols, reports, engineering drawings, procedures, and other product development documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Support product maintenance for currently marketed products, as necessary.
• Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications and internal Letters to File, as applicable.
• Prepare and oversee documentation packages for submission to global regulatory agencies; track timelines and document milestone achievements for inclusion in regulatory submissions; interact with regulatory agencies as part of submission review and on-site audit support for CE marking Technical Documentation under MDD/MDR.
• Review and approve device labeling and marketing materials for compliance with applicable regulations and claims.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Author regulatory documents under minimal supervision and serve as in-house regulatory expert to internal and external stakeholders.
• Monitor proposed and current US and EU regulations and guidance and advise on the impact of such regulations.
• Provide technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams.
• Identify and evaluate regulatory processes and systems for improvements ensuring compliance.
• Support Post Market Surveillance activities, including the Clinical Evaluation Report (CER) and Periodic Safety Update Report (PSUR).
• Assist with customer complaints/CAPA system.
• Maintain and increase professional and technical knowledge by on-the-job training, attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
• Perform special projects and other duties as assigned.
EDUCATION AND/OR EXPERIENCE
Required
• Bachelor’s degree in Engineering, Science or Regulatory Affairs.
• A minimum of seven years’ experience in an FDA regulated industry required, preferably with medical devices.
• Experience supporting FDA inspections and Notified Body audits.
• Strong working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
• Strong working knowledge of US and EU regulations that affect Class II and IIa medical devices.
• Experience working on cross functional projects.
Bonus
• RAPS Certification (RAC) experience.
SKILLS, ABILITIES, AND CHARACTERISTICS
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Excellent English communication skills (both written and verbal), including negotiating and relationship management skills.
• Excellent planning and organizational skills.
• Excellent analytical thinking and problem solving skills.
• Ability to support multiple projects and balance priorities.
• Ability to manage competing priorities in a fast-paced environment.
• Tech savvy: proficiency in Microsoft Office applications, quality management systems such as Qualio or MasterControl, and in mobile/cloud resources; comfortable learning new technical systems as needed such as Box, Zoom, Slack, Smartsheet, and Concur, and working in a paperless environment. Ability to overcome barriers and operate in a virtual organization.
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
• Travel (Distributed Workforce) – Approximately 5% of time will be spent traveling for team meetings, conferences, or meetings. • Physical Demand – While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Physical effort required by handling objects of 25 pounds or more occasionally and/or up to 10 pounds frequently. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Mental Demand – Moderate to high degree of concentration due to volume, complexity, and/or “pressure” of work. Ability to make critical thinking skills decisions under pressure.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of all employees assigned to this position. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
In addition to offering a great culture and work environment, Vertos also offers the following benefits:
Health Insurance
• Medical
• Dental
• Vision
• Basic Life and AD&D
• Supplemental Life & AD&D
• Long-Term Disability
• Health Care and Dependent Care Flexible Spending Accounts (FSAs)
• Health Savings Accounts (HSAs) with employer contribution
Paid Time Off
• Paid Time Off
• Paid Holidays
• Jury/Witness Duty Leave
• Bereavement Leave
• Parental Leave Salary Continuation
• Short-Term Disability Salary Continuation
Other Benefits
• 401(k) Retirement Savings Plan with employer match
• Employee Assistance Program
• Voluntary Accident, Critical Illness, Hospital Indemnity and Legal
• Access to BenefitHUB discounts for 200,000 + vendors
