Job Posting for Regulatory and Compliance Analyst at ory and Compliance Analyst at MedSec
MedSec is exclusively dedicated to the unique challenge of medical device and healthcare cybersecurity. MedSec partners with medical device manufacturers and healthcare delivery organizations to help address cybersecurity in medical devices throughout all stages of the device lifecycle. With medical device manufacturers, MedSec leverages its cybersecurity expertise, coupled with its intimate knowledge of the healthcare regulatory and operating environments to offer support in design, architecture, verification, penetration testing, risk assessments, regulatory filings, and execution of security best practices in the development of new medical devices as well legacy systems. With Healthcare Delivery Organizations MedSec leverages its intimate knowledge of medical devices to offer software solutions for cybersecurity and asset management of connected medical devices in hospitals. MedSec is an active participant in helping move the cybersecurity healthcare community forward and participates in a number of standards and best practice committees involved in furthering cybersecurity for medical products.
We are looking for a Regulatory and Compliance Analyst with a proven track record of auditing, documentation and procedural reviews, multi-tasking, coordinating, triaging communications, and other activities as required. In addition, excellent technical writing and presentation skills and strong collaboration, influence, and negotiation skills to align the organization around prioritization around regulatory intelligence would be an asset.
The Quality Assurance and Regulatory Affairs Analyst is responsible for providing support and consultation in assuring that products developed by Medical Device Manufacturers (MDMs) and business processes comply with the applicable medical device regulations in various countries.
Assists in identifying, analyzing, and performing research on all applicable medical device regulations and standards for the regions in which products are to be marketed, including but not limited to the United States, Canada, Europe, Australia, and other markets.
Provides subject matter expertise and consultation in the interpretation of applicable medical device regulations and standards for security as they apply to medical device products, processes, and procedures.
Provides necessary product development support in the following regulatory affairs activities:
Pre-submission, Q-Sub meetings, and other FDA submission-related activities
Reviews product artifacts that require regulatory affairs oversight to ensure compliance with applicable medical device regulations and standards, including product labeling.
Reviews changes to existing products and provides recommendations as to whether new/revised submissions, registrations, licenses, or certificates are required.
Develops and maintains regulatory deliverables for each product with respect to security by actively participating as team members on all assigned new product releases.
Creates and implements regulatory plans to ensure all requirements are met for applicable markets in a timely manner.
Provides necessary support in training, and advisory to ensure compliance with all applicable security standards and regulations.
Supports internal and external audits and inspections, as required.
Provides necessary support in establishing and implementing procedures in the Quality Management System for regulatory affairs activities for compliance with applicable medical device regulations, cybersecurity, and standards.
Provides necessary support in investigations and resolving compliance problems or questions received from customers, regulatory agencies, and other sources, as required.
Collaborates with other team members and business units as required.
A level of education, training, and experience equivalent to graduation from a recognized post-secondary institution
Minimum 4 years of experience in Quality Management System audits and compliance activities for medical device products
Regulatory Affairs Professional certification and/or ISO 13485 lead auditor certification is an asset but not required
Knowledge of risk management (14971) and security risk management TIR57
Understanding of security regulations and standards for compliance
Demonstrated ability to work independently and collaboratively, resolve administrative issues/problems, prioritize workload, and be flexible to meet and adapt to changes in organizational priorities.
Demonstrated ability to use Microsoft Office and/or Google Productivity Suite applications, including word processing, spreadsheet, and presentation software, at an advanced level.
Demonstrated organizational skills and ability to prioritize workload and work under time pressures to meet deadlines.
Demonstrated ability to communicate effectively both verbally and in writing, including the ability to respond professionally, courteously, and in a clear manner.
Demonstrated interpersonal and time management skills.