Sr Director, Regulatory

Job Summary

In this high profile role, the Senior Director or Director or Associate Director, Regulatory Affairs will be an integral part of the regulatory affairs team with the responsibility to support the strategic and organizational direction of the regulatory affairs team. The individual in this role will be responsible for providing direction and leading a global regulatory affairs team in the maintenance and documentation of domestic and international regulatory filings and registrations. The individual in this role will provide direction and guidance in the strategy for obtaining and maintaining global regulatory approvals to support the corporation's global commercial distribution goals.

As a management representative of the Regulatory Affair's department, the Senior Director or Director or Associate Director will be required to formulate and review regulatory strategies for new product and modified products under development. The incumbent exercises sound and strategic judgment in determining appropriate regulatory actions. The incumbent provides leadership, expertise, organizational ability, and multi-tasking skills to help lead cross-functional initiatives.

Duties & Responsibilities

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes.
• Responsible for supporting the company's worldwide regulatory filings and obtaining the required regulatory approvals to market the company's products.
• Represent Regulatory Affairs on project teams and management review meetings.
• Review advertising, labeling, and public communications for regulatory compliance issues.
• Review and approve design, development, and operations change orders and software change orders.
• Ensure compliance to design control regulations during product development and delivery activities.
• Responsible for keeping the management team informed of regulatory status of products.
• Assist in representing the Company before US and international regulatory authorities.
• Provide counsel, training, and interpretation of FDA and other regulatory requirements to cross-functional teams.
• Work with marketing to help identify global registration priorities.
• Direct, plan, delegate, and manage department budget and staff including:
• Hire, promote, demote, reclassify or terminate employees
• Write and conduct performance appraisals and disciplinary actions plans
• Make salary decisions (pay increases or new hire offers)
• Create training and employee development plans
• Handle all departmental employee relations issues

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Extensive experience leading a global medical device Regulatory Affairs team.
• Strong technical abilities to quick learn and understand different medical device technologies.
  
  
  
  • Must know regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submissions.
  
  
• Experienced in FDA QSR requirements and ISO 13485 requirements.
• Experienced in US and international regulatory filings.
• Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, quality, manufacturing, sales, and marketing.
• Good conceptual, analytical, problem solving, and organizational skills.
• A "hands-on" individual, who enjoys challenges, is capable and dedicated to getting the job done with minimal support and direction.
• An assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude, and a sense of urgency to get things done.
• Ability to use common sense and judgment, to build, motivate and manage a strong regulatory organization.
• Well-organized and accustomed to maintaining excellent records.

Preferred Qualifications

• For Associate Director: Minimum 5 years of managerial experience in Regulatory Affairs activities, or related field.

For Director: Minimum 7 years of managerial experience in Regulatory Affairs activities, or related field.

For Senior Director: Minimum 9 years of managerial experience in Regulatory Affairs activities or related field.

• Experience in reviewing clinical protocols and clinical test reports.
• Experience leading Clinical Evaluation Report (CER) activities.
• Experience in patient monitor systems, hospital-based products, software or electronic device products.
• Experience in global regulatory submission requirements (e.g., China, Japan, Korea).

Education

Bachelor's degree is required, preferably in life sciences or engineering. Graduate degree in technical discipline or business management is preferred.

Compensation: The anticipated range for this position is $210,000 - $300,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 25% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.