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 a skilled Regulatory Specialist to join our team at Sol-Millennium. This role is essential for assisting the Quality, R&D, and Project Management teams in the registration of products by preparing the necessary documentation for registrations in the US and Canada. The individual will develop partnerships with other global regulatory functions, affiliates, and stakeholders to define plans and strategies for submissions, address any deficiencies, and develop solutions. Proficiency with Excel and numbers is crucial for analyzing submission numbers and various metrics.
Key Responsibilities:
- Lead, develop and communicate regulatory strategies for new products or changes to existing products to ensure compliance with applicable regulatory agencies (e.g. US Food and Drug Administration “FDA” and Health Canada).
- Prepare and submit product applications (such as 510(k), De Novo 510(k), MDL, MDEL, etc.) to regulatory agencies and respond to additional information inquiries from these agencies.
- Perform regulatory assessments on Engineering Change Requests (ECRs) to determine whether the proposed changes fall within the scope of existing registrations or if new registrations are needed.
- Own and drive respective post activities with regulatory agencies.
- Generate letters to file (LTFs) as appropriate to ensure compliance with regulatory requirements.
- Communicate directly with regulatory agencies and collaborate with stakeholders globally in a timely manner with ownership integrity and responsibility.
- Review labeling and marketing content to ensure compliance with regulatory requirements. Collaborate globally to ensure international labeling compliance.
- Participate in project plans, change control projects, regulatory submission strategy, and risk management.
- Advise project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
- Partner with other regulatory functions for smooth project transition and launch. Be a steward of ownership and collaboration within global regulatory affairs to contribute to a health and positive work environment.
- Support review of change controls to determine the level of change and consequent submission requirements.
- Support pulling reports and metrics related to submissions and approvals. When analytics demonstrate areas for improvement, be involved in continuous improvements.
- Offer country-specific regulatory support where necessary.
Experience Requirements:
- 5+ years of prior experience and a Bachelor’s degree in life sciences, biology, or biomedical fields.
- Experience in 510(k) submissions, presub meetings, AI responses, and MDL submissions required.
- Decision-making and judgment in selecting innovative, practical methods to achieve problem resolution.
- Strong understanding and working experience with FDA and hopefully Health Canada. Other Ministry of Health experience is a plus.
- Ability to influence stakeholders on technical and strategic solutions.
- Adaptable in cultural and political diversity.
- Demonstrate leadership when activities are within area of responsibility.
- Capacity to learn and challenge the status quo.
- Team player and self-motivated.
- Strong background is ownership of areas of responsibility and competencies in past work experiences.
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 based on qualifications, merit, and business need.
