Regulatory Affairs Specialist
3 weeks ago
Vyana Consultancy is seeking a highly skilled Regulatory Affairs professional to join our team. In this role, you will play a critical part in ensuring our organization's products meet the necessary regulatory standards, enabling us to bring safe and effective products to market.
Key Responsibilities:- Develop Regulatory Strategies: Develop and implement regulatory strategies for product approval and market compliance.
- Ensure Compliance: Ensure all regulatory submissions and documentation are accurate and in compliance with relevant regulations.
- Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams to provide regulatory guidance and support.
- Review and Approve Materials: Review and approve product labeling, advertising, and promotional materials for compliance.
- Conduct Regulatory Research: Conduct regulatory research to stay updated on changes in regulations and guidelines.
- Prepare Regulatory Filings: Prepare and submit regulatory filings, including 510(k)s, PMAs, and other regulatory submissions.
- Participate in Regulatory Agency Interactions: Participate in regulatory agency interactions and audits.
- Assess Regulatory Impacts: Assess and communicate potential impact of regulatory changes on the business.
- Manage Regulatory Documentation: Manage regulatory documentation and records.
- Develop SOPs and Quality System Regulations: Participate in the development and review of SOPs, work instructions, and quality system regulations.
- Bachelor's Degree: Bachelor's degree in a scientific or technical field, such as biology, chemistry, or pharmacy.
- Regulatory Affairs Experience: 3 years of experience in a regulatory affairs role in the healthcare or pharmaceutical industry.
- Knowledge of FDA Regulations: Knowledge of FDA regulations and other regulatory requirements.
- Regulatory Submissions Experience: Experience with regulatory submissions and approvals, such as 510(k)s, PMAs, or IDEs.
- Quality Management Systems: Strong understanding of quality management systems and regulatory compliance.
- Analytical and Problem-Solving Skills: Excellent analytical and problem-solving skills.
- Communication Skills: Effective written and verbal communication skills.
- Detail-Oriented and Organized: Detail-oriented with strong organizational abilities.
- Collaboration and Cross-Functional Teams: Ability to collaborate and work effectively in cross-functional teams.
- Regulatory Agency Interactions: Experience interfacing with regulatory agencies and notified bodies.
Key Skills: cross-functional collaboration, regulatory strategy, analytical skills, documentation, organizational abilities, regulations, FDA regulations, communication skills, regulatory submissions, quality management systems, compliance, regulatory affairs
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