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SalaryRegulatory Affairs Associate Job Description:
We are seeking a skilled Regulatory Affairs Associate reporting to Director of Regulatory Affairs to join our team to ensure that our products comply with all relevant regulations and laws. The ideal candidate will have a strong understanding of regulatory guidelines and be able to effectively communicate with regulatory bodies, team members, and stakeholders.
Responsibilities:
- Research and interpret regulations related to the development, manufacturing, and marketing of products in the Medical Device industry.
- Review product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Assist in the preparation and submission of regulatory documents, applications, and reports.
- Coordinate communication with regulatory agencies and respond to inquiries or requests for additional information.
- Monitor changes in regulations and communicate updates to relevant stakeholders within the organization.
- Support regulatory inspections and audits, ensuring all necessary documentation is prepared and available.
- Collaborate with cross-functional teams, including R&D, quality, and legal, to ensure regulatory compliance throughout the product lifecycle.
Qualifications:
- Bachelor's or advanced degree in Regulatory Affairs, science, pharmacy, or a related field.
- 2+ years of experience in Regulatory Affairs within the Medical Device industry.
- Strong knowledge of FDA, EU, and other international regulations.
- Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely.
- Detail-oriented and able to manage multiple projects simultaneously.
- Experience working with regulatory submissions, including 510(k) or CE Mark applications or International Registration, is preferred.
- Ability to work effectively both independently and in a team environment.
- Licenses/ Certifications: RAC Preferred
- Travel Required: 5-15%
If you have a passion for ensuring product compliance and a desire to work in a fast-paced, dynamic environment, we encourage you to apply for our Regulatory Affairs Associate position.
