30 Oct
Vyana Consultancy
Junagadh
Overview: The Regulatory Affairs role is crucial to our organization as it ensures compliance with all regulations and guidelines governing our industry. This role plays a key part in ensuring that the companys products meet the necessary regulatory standards thereby enabling the organization to bring safe and effective products to market. Key Responsibilities: Developing and implementing regulatory strategies for product approval and market compliance Ensuring all regulatory submissions and documentation are accurate and in compliance with relevant regulations Collaborating with crossfunctional teams to provide regulatory guidance and support Reviewing and approving product labeling advertising and promotional materials for compliance Conducting regulatory research to stay updated on changes in regulations and guidelines Preparing and submitting regulatory filings including 510(k)s PMAs and other regulatory submissions Participating in regulatory agency interactions and audits Assessing and communicating potential impact of regulatory changes on the business Managing regulatory documentation and records Participating in the development and review of SOPs work instructions and quality system regulations Required Qualifications: Bachelors degree in a scientific or technical field such as biology chemistry or pharmacy 3 years of experience in a regulatory affairs role in the healthcare or pharmaceutical industry Knowledge of FDA regulations and other regulatory requirements Experience with regulatory submissions and approvals such as 510(k)s PMAs or IDEs Strong understanding of quality management systems and regulatory compliance Excellent analytical and problemsolving skills Effective written and verbal communication skills Detailoriented with strong organizational abilities Ability to collaborate and work effectively in crossfunctional teams Experience interfacing with regulatory agencies and notified bodies cross-functional collaboration,regulatory strategy,analytical skills,documentation,organizational abilities,regulations,fda regulations,communication skills,regulatory submissions,quality management systems,compliance,regulatory affairs
▶️ (28/10/2024) Regulatory Affairs
🖊️ Vyana Consultancy
📍 Junagadh