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:

• Master'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.

Benefits:

• Competitive salary and benefits package
• Opportunities for professional development and career advancement
• Collaborative and supportive work environment
• 50% coverage of healthcare, dental and vision

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