Regulatory Affairs Specialist Job Description
The Regulatory Affairs Specialist plays a crucial role in ensuring that the company's products and operations comply with all relevant regulatory requirements. You will be responsible for preparing and submitting regulatory documentation and providing guidance on regulatory strategy. Additionally, you will be involved in monitoring and managing changes in regulatory requirements and communicating these changes to relevant stakeholders.
Responsibilities
- Prepare and submit regulatory documentation, such as product registrations, filings, and reports, to government agencies
- Develop and maintain regulatory strategies and plans to ensure compliance with all applicable regulations and standards
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to ensure regulatory requirements are met throughout the product lifecycle
- Provide guidance and support to internal stakeholders on regulatory matters and requirements
- Monitor and analyze changes in regulatory requirements and assess the impact on the company's products and operations
- Ensure the timely and accurate completion of regulatory submissions and ensure compliance with regulatory timelines
- Participate in regulatory inspections and audits, including the preparation of relevant documentation and providing support during inspections
- Stay up-to-date with current and emerging regulations, guidelines, and best practices in the industry
Qualifications
- Bachelor's degree in a scientific or healthcare-related discipline
- Proven experience in regulatory affairs, preferably in the healthcare or medical device industry
- Strong knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and GMP guidelines
- Excellent attention to detail and ability to analyze and interpret complex regulatory requirements
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Ability to prioritize and manage multiple tasks and projects
- Experience with regulatory submissions and interactions with regulatory authorities
- Familiarity with quality management systems and processes
Skills
- Knowledge of FDA regulations and guidelines
- Experience with regulatory submissions
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Attention to detail
- Ability to work effectively in cross-functional teams
- Knowledge of medical device regulations and standards
- Experience with quality management systems