Regulatory Affairs

4 weeks ago


ahmedabad, India Vyana Consultancy Full time
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



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