Director of Regulatory Affairs - Healthcare Setting
- $120,000 - $145,000
- Mount Vernon, NY +1
Fantastic Bronx Based Outpatient Healthcare Organization is Looking to Hire a Director of Regulatory Affairs!!!
A bit about us:
Do you care about uplifting your fellow New Yorkers and giving back to the community?
We are a New York City based community and primary healthcare organization with locations throughout the Bronx!
We serve the underserved and are committed to all New Yorkers having access to quality medical, dental, and mental healthcare, regardless of their socioeconomic status.
Interested in learning more?
CONTACT ME TODAY:
joshua.tacke@jobot.com
949-287-5432
We are a New York City based community and primary healthcare organization with locations throughout the Bronx!
We serve the underserved and are committed to all New Yorkers having access to quality medical, dental, and mental healthcare, regardless of their socioeconomic status.
Interested in learning more?
CONTACT ME TODAY:
joshua.tacke@jobot.com
949-287-5432
Why join us?
- Top Outpatient Community Health Organization in NYC
- Highly competitive base pay
- Great benefits
- PENSION WITH NO EMPLOYEE CONTRIBUTION
- Collaborative culture with friendly team
- Unlimited Growth Opportunities
Job Details
Job Details:
We are seeking an experienced and dynamic Director of Regulatory Affairs in a healthcare setting.
This role is critical in managing and directing all aspects of regulatory affairs within the organization. The successful candidate will be responsible for ensuring that the company is in compliance with all applicable federal, state, and local regulations. This position requires an individual who is certified in healthcare compliance and has a deep understanding of regulatory affairs.
Responsibilities:
1. Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
2. Act as the primary contact with regulatory authorities, handling all communications and submissions.
3. Ensure the company's procedures, operations, and reports are in compliance with laws and regulations.
4. Monitor changes in regulations and the impact of new legislation on the organization's operations.
5. Prepare and manage all regulatory submissions (e.g., FDA, EMA) to ensure timely approvals for new products and changes to existing products.
6. Collaborate with other departments to ensure all systems are in line with current regulations.
7. Develop and conduct regulatory training and education programs for the organization.
8. Oversee risk management activities and ensure they are in line with regulatory requirements.
9. Participate in internal and external audits, ensuring readiness and compliance.
10. Provide regulatory input and advice to the organization's leadership team, helping to shape strategic decisions.
Qualifications:
1. Bachelor’s degree in a related field (Master's degree or higher preferred).
2. Certified in Healthcare Compliance (CHC).
3. Minimum of 3+ years of experience in regulatory affairs or a related field in the healthcare industry - KNOWLEDGE OF JOINT COMISSION, RYAN WHITE, HRSA, ETC
4. Strong knowledge of federal and state healthcare regulations, regulatory affairs, and risk management.
5. Excellent communication and interpersonal skills, with the ability to interact at all levels of the organization.
6. Proven ability to manage multiple projects and meet deadlines.
7. Strong leadership and team-building skills.
8. Ability to interpret and apply knowledge of laws, regulations, and policies related to healthcare compliance.
9. Demonstrated ability to strategically plan and serve as a catalyst for organizational change, cultivate a shared vision with others, and motivate them to transfer vision into action.
10. Ability to travel as needed to interact with regulators, participate in industry events, and support business needs.
We are seeking an experienced and dynamic Director of Regulatory Affairs in a healthcare setting.
This role is critical in managing and directing all aspects of regulatory affairs within the organization. The successful candidate will be responsible for ensuring that the company is in compliance with all applicable federal, state, and local regulations. This position requires an individual who is certified in healthcare compliance and has a deep understanding of regulatory affairs.
Responsibilities:
1. Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
2. Act as the primary contact with regulatory authorities, handling all communications and submissions.
3. Ensure the company's procedures, operations, and reports are in compliance with laws and regulations.
4. Monitor changes in regulations and the impact of new legislation on the organization's operations.
5. Prepare and manage all regulatory submissions (e.g., FDA, EMA) to ensure timely approvals for new products and changes to existing products.
6. Collaborate with other departments to ensure all systems are in line with current regulations.
7. Develop and conduct regulatory training and education programs for the organization.
8. Oversee risk management activities and ensure they are in line with regulatory requirements.
9. Participate in internal and external audits, ensuring readiness and compliance.
10. Provide regulatory input and advice to the organization's leadership team, helping to shape strategic decisions.
Qualifications:
1. Bachelor’s degree in a related field (Master's degree or higher preferred).
2. Certified in Healthcare Compliance (CHC).
3. Minimum of 3+ years of experience in regulatory affairs or a related field in the healthcare industry - KNOWLEDGE OF JOINT COMISSION, RYAN WHITE, HRSA, ETC
4. Strong knowledge of federal and state healthcare regulations, regulatory affairs, and risk management.
5. Excellent communication and interpersonal skills, with the ability to interact at all levels of the organization.
6. Proven ability to manage multiple projects and meet deadlines.
7. Strong leadership and team-building skills.
8. Ability to interpret and apply knowledge of laws, regulations, and policies related to healthcare compliance.
9. Demonstrated ability to strategically plan and serve as a catalyst for organizational change, cultivate a shared vision with others, and motivate them to transfer vision into action.
10. Ability to travel as needed to interact with regulators, participate in industry events, and support business needs.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.