Regulatory Affairs Director - Remote

The Regulatory Affairs Director, North America is responsible for leading the XVIVO's clinical regulatory strategy for the United States and Canada and will play a significant part in the company’s strategic planning and forecasting by providing input on the clinical regulatory process for products through the R&D and post-marketing lifecycles.

Responsible for comprehensive clinical study management and day-to-day tasks, consisting of but not limited to:

• Develop and execute comprehensive regulatory strategies for XVIVO’s product portfolio in the United States and Canada.
• Ensure compliance with all applicable FDA regulations, Health Canada’s Medical Device Regulation (SOR 98-282), ISO 13485 and other relevant quality standards
• Build, lead and support the N. American Regulatory Affairs team, responsible for executing regulatory strategies and supporting product development and commercialization.
• Works closely with Clinical Affairs Director, North America to ensure broad execution of clinical and regulatory activities and regulatory compliance as they pertain to Class II/Class III products.
• Manage communication with FDA and Health Canada, including pre-submission communication (e.g. FDA Q-Sub)
• Oversee regulatory filings including IDE, PMA, De Novo and 510(k)s and Health Canada Eastablishment and Medical Device License (MDL) applications as well as ongoing updates and annual/periodic reports.
• Collaborate with internal and external resources for input to develop strategies to address questions from FDA and/or Health Canada, highlighting XVIVO’s technology advantages and context for risk.
• Supports product development/improvement projects with R&D and Engineering to assure applicable regulatory requirements are met.
• Provides regulatory strategy guidance to clinical and operations departments.
• Supports review of product labeling, literature and company websites for accuracy, consistency and domestic and international regulatory compliance.
• Leads activities for State and Federal regulatory licenses, registrations and listings.
• Supports review of internal operating procedures and other controlled documents to ensure regulatory compliance and consistency with regulatory commitments.
• Researches, prepares and communicates new and changing product regulatory assessments and justifications.
• Assists with the training and development of personnel on Regulatory requirements.
• Supports the Complaint Handling process, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.
• Oversee the processing and reporting of post-market adverse events to FDA and Health Canada.
• Develop and maintain regulatory affairs operating procedures and work instructions.
• Other tasks and responsibilities as assigned or as business needs require.

Team: Fostering a Healthy, Enjoyable, and Engaged Workplace Environment:

• Contribute to a positive and collaborative team culture by promoting open communication, respect, and mutual support.
• Actively participate in team meetings, share knowledge, and best practices to enhance overall team performance.
• Seek opportunities to celebrate team successes and foster a sense of camaraderie.
• Collaborate with colleagues across departments, fostering cross-functional teamwork and synergy.
• Provide constructive feedback and support to team members, promoting personal and professional growth.
• Embrace and promote a healthy work-life balance, ensuring personal well-being and encouraging others to do the same.

Relationship Building:

• Foster strong relationships with key stakeholders, including FDA and hospital sites

Travel:

• Domestic travel required (~25%)
• Some international travel may be required.

WHAT SKILLS AND EXPERIENCE WILL YOU NEED?

• Bachelor’s degree in Life Sciences, Engineering, or other equivalent job experience.
• A minimum of 5 years of experience in regulatory affairs within the medical device industry.
• Excellent working knowledge of FDA and Health Canada regulatory requirements and standards required. Experience with preparing of regulatory submissions/registrations required. PMA/Class III Device (high risk) experience is a must.
• Must work independently with the ability to organize and lead teams and sub-teams to address complex regulatory strategies.
• A team player with a demonstrated capacity to communicate above regulations to technical and marketing functions within the company; possess the ability to handle multiple tasks, and to attend appropriately to details.
• Strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
• Ability to demonstrate the highest levels of integrity, and good interpersonal and presentation skills.
• Proficient computer skills using Microsoft Office products as well as CRM, Quality Management Systems, and experience with Electronic Medical Records (EMR) and Data Capture Forms/Case Report Forms (DCFs/CRFs).
• Able to adapt and execute should strategic goals shift during the life of the project.
• Good command of the English language, spoken and written

WHAT SKILLS WOULD BE HELPFUL?

• Proficiency with 21 CFR 812, 21 CFR 814, and 21 CFR 820, GDPR, HIPAA, EU MDR
• Understanding of anatomy, physiology, and medical terminology
• Ability to proactively drive projects and be persistent in follow-up for tasks required to achieve management timelines
• Ability to handle new challenges and solve unexpected problems

• Salary Pay or Salary Range: $125,000 to $170,000
• Other Compensation: All Employee Bonus Program
• Company Benefits include paid Medical, Dental, Vision, Short Term Disability, Long Term Disability, and Life insurance
• Flexible Time Off
• Sick Time
• 401K Match
• Paid Maternity, Paternity, and Adoption Leave AND
• Well-Being Benefit