Regulatory Affairs Senior Specialist
2 weeks 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. With pioneering solutions and a dedication to excellence, we aim to provide products that improve the quality of care. Our workforce is enthusiastic, motivated, and devoted to making a significant impact in the healthcare sector.
Position Overview: We are looking for an experienced Regulatory Specialist to play a vital role in our organization. This position is crucial for supporting the Quality, Research & Development, and Project Management departments in the registration of products by preparing the required documentation for approvals in the United States and Canada. The selected candidate will cultivate partnerships with various global regulatory teams, affiliates, and stakeholders to establish plans and strategies for submissions, rectify any deficiencies, and devise solutions. Proficiency in Excel and data analysis is essential for evaluating submission metrics and various performance indicators.
Key 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 (such as 510(k), De Novo 510(k), MDL, MDEL, etc.) to regulatory authorities and address any additional information requests from these agencies.
- Conduct regulatory evaluations on Engineering Change Requests (ECRs) to ascertain whether the proposed modifications fall within the scope of existing registrations or necessitate new registrations.
- Oversee and manage respective post-approval activities with regulatory authorities.
- Draft letters to file (LTFs) as necessary to ensure compliance with regulatory mandates.
- Engage directly with regulatory agencies and collaborate with global stakeholders promptly, demonstrating ownership, integrity, and accountability.
- Review labeling and marketing materials to ensure compliance with regulatory standards. Collaborate internationally to guarantee adherence to labeling regulations.
- Participate in project planning, change control initiatives, regulatory submission strategies, and risk management processes.
- Advise project teams on manufacturing modifications, line extensions, technical labeling, relevant regulations, and 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 reviewing change controls to determine the extent of changes and corresponding submission requirements.
- Support the extraction of reports and metrics related to submissions and approvals. When analytics indicate areas for enhancement, engage in continuous improvement efforts.
- Provide country-specific regulatory support as needed.
Experience Requirements:
- A minimum of 5 years of relevant experience and a Bachelor's degree in life sciences, biology, or biomedical disciplines.
- Proven experience in 510(k) submissions, presubmission meetings, AI responses, and MDL submissions is required.
- Ability to make informed decisions and exercise judgment in selecting innovative, practical solutions to resolve issues.
- Strong understanding and hands-on experience with FDA regulations, and ideally Health Canada. Experience with other Ministries of Health is advantageous.
- Capability to influence stakeholders regarding technical and strategic solutions.
- Adaptability to cultural and political diversity.
- Demonstrated leadership in areas of responsibility.
- Willingness to learn and challenge existing norms.
- A collaborative team player who is self-motivated.
- Strong 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 develops. Sol-Millennium Medical Group is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.
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