Compliance Affairs Specialist (Hallandale, FL)
Ferrer Pulmonary InstituteMiami, FL, US30+ days ago
Salary
$65,000.00–$76,000.00 yearly
Job type
- Full-time
Job descriptionMaster's degree in Compliance, Regulatory Affairs, Life Sciences, Pharmacy, or related field preferred. Relevant certification (e.g., RAC) may be considered with demonstrated experience. Minimum of 3 years of experience in regulatory affairs within the healthcare or pharmaceutical industry. Thorough understanding of compliance, regulatory requirements and guidelines, including FDA regulations (e.g., 21 CFR), ISO standards, and ICH guidelines. Strong analytical and problem-solving skills, with the ability to interpret complex regulations and apply them to practical situations. Excellent written and verbal communication skills, with the ability to effectively communicate with internal and external stakeholders. Detail-oriented with strong organizational skills and the ability to manage multiple priorities and deadlines. Proficiency in Microsoft Office Suite and regulatory software applications. Competitive salary and benefits package Opportunities for professional development and career advancement Collaborative and supportive work environment 50% coverage of healthcare, dental and vision
Compliance Affairs Specialist
Position Overview : We are seeking a meticulous and detail-oriented Compliance Affairs Specialist to join our team. The ideal candidate will have a master's degree in compliance, regulatory affairs or a relevant certification, and practical experience in regulatory affairs within the healthcare or pharmaceutical industry.
Responsibilities :
- Develop and implement compliance or regulatory strategies to ensure compliance with applicable regulations and standards governing the development, manufacturing, and marketing of medical devices and medications.
- Prepare and submit compliance and regulatory submissions to regulatory authorities, including but not limited to FDA, EMA, and other global regulatory agencies.
- Coordinate with cross-functional teams, including R&D, quality assurance, and legal, to ensure compliance and regulatory requirements are integrated into product development processes.
- Interpret and communicate compliance and regulatory requirements to internal stakeholders, providing guidance on regulatory implications and potential risks.
- Monitor and assess changes to regulations and standards, recommending and implementing appropriate actions to maintain compliance.
- Support regulatory inspections and audits, including preparing documentation and facilitating interactions with regulatory authorities.
- Maintain compliance and regulatory documentation and records in accordance with company policies and regulatory requirements.
Qualifications :
Benefits :
Location : 850 NW 42nd Ave Miami FL 33126
Job Type : Full-time
Pay : $65,000.00 - $76,000.00 per year
Schedule : 8 hour shiftMonday to Friday
Work Location : In person