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Director Regulatory Affairs

3 months ago

Remote, Oregon, United States Intelerad Medical Systems Full time

Company Description

At Intelerad, we believe the path to answers in healthcare should be clear-whether you are waiting for a diagnosis or trying to expedite one. Our medical imaging solutions streamline the flow of information, simplifying complex processes, maximizing efficiencies, and shining a light on the unknown. We empower physicians to get patients the answers they need faster and improve outcomes for everyone. With more accessible imaging, we are getting patients out of the dark.

Headquartered in Raleigh, NC and Montreal, Intelerad has nearly 800 employees located in offices across six countries. The company empowers nearly 2,000 healthcare organizations around the world with the speed, scalability, and simplicity needed to increase business performance while, most importantly, improving patient outcomes. Intelerad's modern enterprise solutions have been acknowledged by a Best in KLAS recognition, ranking #1 for PACS Asia/Oceania in the 2021 Best in KLAS: Global Software (Non-US) report. unles

Job Description

The Director, Regulatory Affairs and Quality Management, will lead the regulatory and quality strategy and operations to ensure compliance with all relevant regulatory requirements, globally, with a specific focus on FDA and Medical Device Regulation (MDR) as applied to Software as a Medical Device (SaMD). The ideal candidate has experience in medical device technology and is capable of navigating the global regulatory landscape to ensure successful product approvals.

Management Responsibilities:

  • Lead a high-performing regulatory and quality affairs team (team of five), fostering a culture of compliance and continuous improvement.
  • Provide strategic direction and mentorship to the regulatory and quality affairs team, ensuring alignment with organizational objectives.
  • Establish goals for the team and individual team members using knowledge of the industry in alignment with organizational objectives.
  • Lead Management Review with Executive Team and Board

Additional Duties:

  • Lead the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals.
  • Coordinate with regulatory authorities, including the FDA, European and Australian regulatory bodies to facilitate the approval process.
  • Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global regulatory requirements for medical devices.
  • Monitor and interpret regulatory developments and trends, advising General Counsel and Leadership Team on potential impacts
  • Collaborate with cross-functional teams, including R&D, Product, and Marketing to integrate regulatory requirements into product development processes.
  • Implement robust risk management practices to identify and mitigate regulatory risks.
  • Ensure alignment with quality management systems (QMS) and regulatory standards, including but not limited to, 21 CFR 820, ISO 13285, and ISO 27001
  • Oversee regular audits of the departments to ensure compliance with procedures
  • Provide input into the department Budgeting process
  • This job description may not be inclusive of all assigned duties and the scope of the job may change as necessitated by business demands.

Qualifications

  • Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs, quality management)
  • 10+ years of regulatory affairs experience in the medical device industry, with a strong focus on FDA and SaMD
  • Knowledge of 21 CFR, ISO13485 and ISO 27001
  • Experience in the IT field, software development, and/or cloud hosting preferred
  • Training in quality management and quality improvement processes
  • Strong leadership and team management skills, with the ability to inspire and guide a diverse team
  • Excellent communication and negotiation skills, with the ability to interact effectively with regulatory authorities and cross-functional teams
  • Flexible, positive and well-organized team player, comfortable working in a fast-paced software and technology environment

#LI-REMOTE

Additional Information

All your information will be kept confidential according to EEO guidelines.

All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.

Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age (40 or older), disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.

Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act ("ADA")as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines "disability" as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment.