Regulatory Affairs Senior Specialist
1 week ago
About Sol-Millennium Medical Group: Sol-Millennium Medical Group is a worldwide healthcare organization committed to enhancing the safety and welfare of patients and healthcare professionals. Through innovative solutions and a dedication to excellence, we aim to provide products that improve the quality of care. Our team is enthusiastic, driven, and focused on making a significant impact in the healthcare sector.
Position Overview: We are in search of an experienced Regulatory Specialist to contribute to our efforts at Sol-Millennium Medical Group. This position plays a crucial role in supporting the Quality, Research & Development, and Project Management teams in the product registration process by preparing essential documentation for submissions in the US and Canada. The selected candidate will cultivate relationships with other global regulatory functions, affiliates, and stakeholders to outline plans and strategies for submissions, address any gaps, and devise solutions. Proficiency in Excel and data analysis is vital for evaluating submission metrics and various performance indicators.
Primary Responsibilities:
- Develop, articulate, and implement regulatory strategies for new products or modifications to existing products to ensure adherence to relevant regulatory bodies (e.g., US Food and Drug Administration "FDA" and Health Canada).
- Prepare and submit product applications (including 510(k), De Novo 510(k), MDL, MDEL, etc.) to regulatory authorities and address requests for additional information from these bodies.
- Conduct regulatory evaluations on Engineering Change Requests (ECRs) to ascertain whether the proposed modifications fall within the existing registrations or necessitate new registrations.
- Manage and oversee respective post-approval activities with regulatory agencies.
- Draft letters to file (LTFs) as necessary to ensure compliance with regulatory standards.
- Engage directly with regulatory authorities and collaborate with global stakeholders in a timely manner, demonstrating ownership, integrity, and accountability.
- Review labeling and marketing materials to confirm compliance with regulatory standards. Collaborate internationally to ensure compliance with global labeling requirements.
- Participate in project planning, change control initiatives, regulatory submission strategies, and risk management processes.
- Advise project teams on manufacturing alterations, line extensions, technical labeling, relevant regulations, and their interpretations.
- Collaborate with other regulatory functions to ensure smooth project transitions and launches. Foster a culture of ownership and teamwork within global regulatory affairs to contribute to a healthy and positive work environment.
- Assist in the review of change controls to determine the extent of changes and the associated submission requirements.
- Support the generation of reports and metrics related to submissions and approvals. When analytics reveal areas for enhancement, engage in continuous improvement efforts.
- Provide country-specific regulatory assistance as needed.
Qualifications:
- Minimum of 5 years of relevant experience and a Bachelor's degree in life sciences, biology, or biomedical disciplines.
- Experience with 510(k) submissions, presubmission meetings, AI responses, and MDL submissions is essential.
- Demonstrated decision-making and judgment in selecting innovative, practical methods for problem resolution.
- Strong understanding and hands-on experience with FDA regulations and ideally Health Canada. Experience with other health ministries is advantageous.
- Ability to influence stakeholders regarding technical and strategic solutions.
- Adaptability to cultural and political diversity.
- Exhibit leadership when activities fall within the scope of responsibility.
- Capacity to learn and challenge existing practices.
- Team-oriented and self-driven.
- Proven track record of ownership in areas of responsibility and competencies in previous roles.
This job description is not exhaustive and may evolve as the business progresses. Sol-Millennium Medical Group is an equal opportunity employer. We celebrate diversity and are dedicated to fostering an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.
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