Job Title: Director of Regulatory Affairs

Job Description:

As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes, you will lead the development and implementation of regulatory strategies, manage submissions to regulatory agencies, and oversee compliance activities. Your expertise will be critical in navigating the complex regulatory landscape to bring innovative medical devices to market and maintain compliance throughout the product lifecycle.

Your primary responsibilities will include:

Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies to ensure timely and successful product approvals. Provide regulatory guidance to cross-functional teams, including R&D, quality, and marketing, to align product development with regulatory requirements.

Submission Management: Lead the preparation, submission, and management of regulatory filings, including pre-market notifications (510(k)), pre-market approvals (PMA), Technical Files, and other submissions to global regulatory agencies (e.g., FDA, EMA, TGA). Ensure accuracy, completeness, and compliance with regulatory standards.

Regulatory Compliance Oversight: Ensure ongoing compliance with regulatory requirements, including ISO standards, FDA regulations, and other applicable global standards. Oversee the development and maintenance of regulatory documentation, including design dossiers, technical files, and product labeling.

Regulatory Intelligence and Advocacy: Monitor and analyze regulatory developments, changes in legislation, and emerging trends in the medical device industry. Advocate for the company's interests by engaging with regulatory authorities, industry groups, and stakeholders to influence regulatory policy and practices.

Risk Management and Mitigation: Identify and assess regulatory risks associated with product development and commercialization. Develop and implement risk mitigation strategies to address potential compliance issues and ensure successful product approvals.

Team Leadership and Development: Lead, mentor, and develop a high-performing regulatory affairs team. Foster a culture of continuous improvement, collaboration, and professional growth. Provide coaching, feedback, and performance evaluations to optimize team effectiveness and productivity.

Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, quality assurance, clinical, and marketing, to ensure regulatory requirements are integrated into product development and commercialization processes. Provide regulatory expertise and support for clinical trials, product launches, and post-market activities.

Qualifications:

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree (e.g., Master's, PhD) or regulatory affairs certification (RAC) preferred.
• Minimum of 10 years of experience in regulatory affairs within the medical device industry, with at least 5 years in a leadership or management role.
• Deep understanding of global regulatory requirements, including FDA, EU MDR, ISO standards, and other international regulations.
• Proven track record of successful regulatory submissions and approvals for medical devices.
• Strong leadership, communication, and interpersonal skills, with the ability to build effective relationships with regulatory authorities, cross-functional teams, and external partners.
• Excellent analytical and problem-solving abilities, with a strategic mindset and attention to detail.
• Proficiency in regulatory software and tools, as well as familiarity with electronic submission processes and regulatory information management systems.

Compensation and Benefits:

• Competitive base salary, performance-based bonuses, and executive-level incentives commensurate with experience, qualifications, and industry standards.
• Comprehensive benefits package, including health, dental, and vision insurance, retirement savings plan, and employee wellness programs.
• Opportunities for career advancement, professional development, and executive education to support personal growth and leadership development within the medical device industry.

How to Apply:

Interested candidates should submit a resume and cover letter outlining their qualifications, relevant experience, and interest in the role of Director of Regulatory Affairs. Please include "Director of Regulatory Affairs Application - [Your Name]" in the subject line. We thank all applicants for their interest, and only those selected for an interview will be contacted.