Regulatory Affairs Expert for Medical Devices and Pharmaceuticals
6 days ago
Ferrer Pulmonary Institute seeks a detail-oriented Regulatory Affairs Specialist to ensure compliance with regulations and standards in the development, manufacturing, and marketing of medical devices and medications.
Key Responsibilities:
- Develop and implement compliance strategies to ensure adherence to regulatory requirements
- Prepare and submit regulatory submissions to authorities such as FDA and EMA
- Collaborate with cross-functional teams to integrate compliance requirements into product development processes
- Interpret and communicate regulatory requirements to stakeholders and provide guidance on implications and risks
- Monitor and assess changes to regulations and standards, recommending appropriate actions to maintain compliance
- Support regulatory inspections and audits, preparing documentation and facilitating interactions with authorities
Requirements:
- Masters degree in Compliance, Regulatory Affairs, Life Sciences, or related field preferred; relevant certification may be considered with demonstrated experience
- Minimum 3 years of experience in regulatory affairs within the healthcare or pharmaceutical industry
- Thorough understanding of regulatory requirements and guidelines, including FDA regulations (e.g., 21 CFR), ISO standards, and ICH guidelines
- Strong analytical and problem-solving skills, with ability to interpret complex regulations and apply them to practical situations
- Excellent written and verbal communication skills, with ability to effectively communicate with internal and external stakeholders
- Detail-oriented with strong organizational skills and ability to manage multiple priorities and deadlines
Benefits:
- Competitive salary and benefits package
- Opportunities for professional development and career advancement
- Collaborative and supportive work environment
Location: Miami, FL
Salary: $65,000 - $76,000 per year
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