Healthcare Regulatory Compliance Manager at Nuance
Nuance is the pioneer and leader in conversational artificial intelligence (AI) innovations that bring intelligence to everyday work and life. We deliver solutions that understand, analyze, and respond to people, amplifying human intelligence to increase productivity and improve security. With decades of both domain and AI expertise, we work with thousands of organizations across a wide range of industries.
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Join our team! At Nuance, we are constantly reinventing how people connect with technology and with each other. Our AI-powered solutions empower organizations to transform “business as usual.” For decades, the world’s leading financial, healthcare, telecommunications, retailers, and government organizations have trusted Nuance to bring them award-winning solutions that deliver more meaningful outcomes and empower a smarter, more connected world. From clinical speech recognition technologies that free physicians to spend more time caring for patients to real-time intelligence that powers billions of customer interactions, we’re deeply committed to helping organizations push the boundaries of what’s possible.
Nuance is looking to add to our Healthcare Compliance team, and we are hiring a new Regulatory Compliance Manager that will help Nuance build out its FDA regulatory program. While this individual will not manage people, they will be responsible for developing, implementing and overseeing programs, policies, and procedures that ensure our Healthcare compliance programs and privacy policies are effective and efficient in identifying, detecting, and correcting non-compliance with applicable laws, regulations and policies. This person will also help instill and maintain a culture of compliance and adherence to applicable laws and regulations. The role will need to work out of our Burlington, MA HQ facility (once we return to our offices sometime in 2021). The role will work directly for our Senior Managing Privacy Legal Counsel.
- Develop compliance programs to assist the healthcare business, policies, and procedures to prevent, detect, and resolve instances of conduct that do not conform to applicable law, regulation, or Nuance policy.
- Assess applicability of medical device regulations, as well as other healthcare regulations.
- Serve as a trusted advisor and partner to employees at all levels of the organization.
- Identify potential areas of compliance vulnerability and risk, develop and implement action plans for resolution of challenges, and provide general guidance on how to avoid or deal with similar situations in the future.
- Maintain a current working knowledge of actual, proposed, or pending legislation, regulations, and policies that affect the business.
- Develop and deliver educational and training programs to employees and other key relationships.
- Investigate compliance concerns, questions, or complaints.
- Develop and track metrics, benchmarks and success criteria to measure the efficiency and effectiveness of the various programs and processes.
- Performs other duties as required or assigned by management.
Education: Bachelor’s Degree
Years of Experience: 5+ years of experience in healthcare compliance
- Experience with FDA Analysis
- Ability to collaborate with all levels of the business
- Excellent interpersonal, communication, and problem-solving skills, including the ability to communicate clearly and concisely with management
- Seeks to understand business issues and deliver pragmatic, impactful guidance
- Adapts and succeeds when working across cultures
- Self-motivated, highly responsive, team player with the ability to drive projects, identify and resolve issues
- Strong organizational skills and ability to multi-task
- Strong computer skills required
- Experience with FDA Filings
- Experience with Anti-Kickback and Stark Laws
- Experience and comfort working with International organizations
Nuance offers a compelling and rewarding work environment. We offer market competitive salaries, bonus, equity, benefits, meaningful growth and development opportunities and a casual yet technically challenging work environment. Join our dynamic, entrepreneurial team and become part of our continuing success.
Nuance celebrates diversity and is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by law or Nuance policy. If you need an accommodation because of a disability for any part of the employment process, please call 781-565-5086 and let us know.