We are seeking a Regulatory Affairs Specialist to ensure compliance with medical device regulations and standards. In this role, you will prepare and submit regulatory filings, monitor changes in regulations, and provide guidance to internal teams. Your expertise will help ensure the safety and efficacy of our products.

Key Responsibilities:
* Prepare and submit regulatory filings to relevant agencies.
* Monitor changes in regulations and standards.
* Provide guidance to internal teams on regulatory requirements.
* Maintain accurate documentation of regulatory activities.
* Participate in regulatory audits and inspections.

Required Skills:
* Knowledge of medical device regulations (e.g., FDA, CE).
* Experience in preparing regulatory submissions.
* Strong attention to detail and accuracy.
* Excellent communication and writing skills.