Director Of Regulatory Affairs

About Sol-Millennium:

Sol-Millennium is a global healthcare company dedicated to improving the safety and well-being of patients and healthcare providers. With innovative solutions and a commitment to excellence, we strive to deliver products that enhance the quality of care. Our team is passionate, driven, and committed to making a difference in the healthcare industry.

Job Overview:

We are seeking an experienced and dynamic Director of Regulatory Affairs to join our team As the Director of Regulatory Affairs, you will be responsible for building and maintaining a global regulatory team, collaborating with quality, sourcing, marketing, R&D, and other functions to ensure our products are of the highest quality and compliant with all regulations. You will oversee the preparation, submission, and maintenance of regulatory filings, and develop and implement comprehensive regulatory strategies to support the company's business objectives across different markets.

In this role, you will monitor and analyze regulatory trends, perform gap assessments, and develop compliance strategies to meet new requirements. You will also lead and mentor global regulatory teammates, fostering a culture of compliance, continuous improvement, and collaboration. Additionally, you will represent Sol-Millennium in interactions with regulatory authorities, ensuring effective communication and alignment with regulatory requirements.

Key Responsibilities:

• This position will be responsible for building and maintaining a global team responsible for collaborating with quality sourcing, marketing, R&D and other functions to ensure products (new and existing) are high quality and compliant with all relevant regulations and standards.
• Oversee the preparation, submission and maintenance of regulatory filings.
• Develop and implement comprehensive regulatory strategies to support the company's business objectives across different markets.
• Monitor and analyze regulatory trends, perform gap assessments and develop a compliance strategy for the company to meet the new requirements.
• Lead and mentor global regulatory teammates and foster a culture of compliance, continuous improvement and collaboration.
• Represent the company in interactions with regulatory authorities.

Minimum Qualifications:

• 10 years of Regulatory experience, with at least 6 years of management experience
• Bachelors in Engineering, science or relevant fields

Preferred Qualifications:

• Proven track record of setting and executing regulatory strategies for submission and registration of products in the US, Canada, Europe, Brazil and Asia.
• Experience communicating directly with US FDA, Health Canada and Notified bodies.
• Experience with submitting product registrations and obtaining clearances such as 510(k)'s and De Novo 510(k)'s.

Critical Skills:

• Excellent problem-solving stills

• Excellent communication skills to effectively interact with business partners, internal teams and regulatory authorities

• Detail-oriented with a high degree of accuracy and thoroughness

• Highly capable of independently making decisions based on quality data and regulatory requirements

• Exceptional ability to organize and prioritize ongoing projects

About Sol-Millennium:

We are a global healthcare company dedicated to building a healthier tomorrow through the development, manufacture, and distribution of high-quality medical devices.

Visit our "About Us" page to learn more! https://naca.sol-m.com/about⠀⠀⠀ ⠀

This job description is not intended to encompass all duties that may be required. Additional responsibilities in line with the original scope of work may arise as the business evolves. Sol-Millennium is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need.