Director, Regulatory

Masimo Corporation; Wes-Kaap; On-site; ZAR 80 000 - 150 000; Full time

Job summary

An established industry player is seeking a Senior Director of Regulatory Affairs to lead a global team in navigating complex regulatory landscapes. This pivotal role involves formulating strategies for product approvals, ensuring compliance with FDA and international standards, and representing the company before regulatory authorities. The ideal candidate will possess extensive experience in medical device regulations, excellent leadership skills, and a strong background in cross-functional collaboration. Join this dynamic team to make a significant impact on product development and market access in a thriving environment.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Time Off

Wellness Programs

Qualifications

• Extensive experience leading a global medical device Regulatory Affairs team.
• Knowledge of FDA Class II medical devices and international submission requirements.

Responsibilities

• Manage and lead the Regulatory Affairs organization in developing strategies.
• Support worldwide regulatory filings and secure necessary approvals.

Skills

Regulatory Affairs Leadership

FDA Class II Medical Devices Knowledge

Communication Skills

ISO Standards Knowledge

Global Regulatory Submissions

Education

Bachelor's Degree in Life Sciences or Engineering

Graduate Degree in Related Field

Job description

Job Summary

In this high-profile role, the Senior Director, Director, or Associate Director of Regulatory Affairs will be an integral part of the regulatory affairs team, responsible for supporting the strategic and organizational direction of the department.

The individual will lead a global regulatory affairs team in maintaining and documenting domestic and international regulatory filings and registrations.

This role involves providing guidance on strategies to obtain and maintain global regulatory approvals to support the company's international distribution goals. As a management representative, the person will formulate and review regulatory strategies for new and modified products under development.

The incumbent exercises sound, strategic judgment in determining appropriate regulatory actions and provides leadership, expertise, and organizational skills to lead cross-functional initiatives.

Duties & Responsibilities

1. Manage and lead the Regulatory Affairs organization in developing and implementing regulatory strategies and processes.
2. Support worldwide regulatory filings and secure necessary approvals to market products.
3. Represent Regulatory Affairs on project teams and management review meetings.
4. Review advertising, labeling, and public communications for regulatory compliance.
5. Review and approve design, development, and operations change orders, including software updates.
6. Ensure compliance with design control regulations during product development and delivery.
7. Keep management informed of the regulatory status of products.
8. Represent the company before US and international regulatory authorities.
9. Provide training and interpretation of FDA and other regulatory requirements to cross-functional teams.
10. Collaborate with marketing to identify global registration priorities.
11. Manage department budget and staff, including hiring, promotions, and performance appraisals.

Minimum & Preferred Qualifications

Minimum Qualifications: Extensive experience leading a global medical device Regulatory Affairs team, knowledge of FDA Class II medical devices and international submission requirements, experience with FDA QSR and ISO standards, and excellent communication skills.

Preferred Qualifications: For Associate Director: 5+ years managerial experience; for Director: 7+ years; for Senior Director: 9+ years. Additional experience in clinical protocols, clinical evaluation reports, and global regulatory submissions is preferred.

Education

Bachelor's degree in life sciences or engineering is required; a graduate degree in a related technical or business field is preferred.

Compensation & Benefits

The position offers a salary range, with actual placement based on skills, education, and experience, plus up to 25% annual bonus. Benefits include medical, dental, vision, life insurance, disability, paid time off, and other wellness programs.

Work Environment

This role is primarily office-based, requiring frequent sitting, standing, walking, and daily use of digital devices. Some local travel is required, and accommodations may be made for disabilities.