VP Quality and Regulatory--Raleigh Office Based

The Raleigh NC office based Vice President of Quality and Regulatory (QARA) will oversee all quality and regulatory activities of the company ensuring the highest standards are met and supporting the company's long-term vision. This role involves strategic leadership, policy development, and the implementation of efficient and effective quality management systems to meet regulatory requirements and enhance product quality. The VP of QARA will set the vision for the Quality and Regulatory team and partner with our operating leaders to support our mission and priorities of the company.

Essential Functions

• Strategic Leadership:
• Develop and implement quality and regulatory strategies aligned with the company's goals and objectives.
• Lead the Quality and Regulatory teams, fostering a culture of continuous improvement and compliance.
• Regulatory Compliance:
• Ensure compliance with all relevant regulatory requirements, including FDA (US), MHRA (UK), EMA (EU), ISO, and other international standards.
• Oversee the preparation and submission of regulatory filings and documentation.
• Stay up to date with key regulatory changes and trends
• Quality Management:
• Develop, implement, and maintain quality management systems (QMS) to ensure product quality and safety
• Conduct regular audits and inspections to identify areas for improvement and ensure compliance.
• Partner with the CIO and the CTO to ensure QMS meets proper ISO standards within the Cyber and SaaS delivery models.
• Risk Management:
• Identify and mitigate risks related to product quality and regulatory compliance.
• Develop and implement risk management strategies and corrective action plans.
• Establish a proactive risk management framework to anticipate and mitigate potential quality and regulatory risks
• Collaboration and Communication:
• Collaborate with cross-functional teams, including R&D, IT, Cloud Ops, and marketing, to ensure quality and regulatory requirements are met.
• Communicate effectively with regulatory agencies, customers, and internal stakeholders.
• Training and Development:
• Provide training and development opportunities for the Quality and Regulatory teams.
• Stay updated on industry trends, regulatory changes, and best practices.
  

Skills Needed To Be Successful

• Strategic Thinking: Ability to think strategically and align quality and regulatory initiatives with the company's long-term goals
• Leadership: Strong leadership skills with the ability to inspire and motivate teams.
• Regulatory Knowledge: In-depth knowledge of regulatory requirements and quality management systems (FDA, ISO, and other international standards).
• Analytical Skills: Strong analytical and problem-solving skills to analyze complex data and develop actionable strategies.
• Communication: Excellent verbal and written communication skills to effectively communicate with regulatory agencies, customers, and internal stakeholders.
• Project Management: Strong project management skills with the ability to manage multiple projects simultaneously.
• Attention to Detail: High level of attention to detail and accuracy.
• Adaptability: Ability to adapt to changing regulatory environments and business needs.
  
  

Required Experience & Education

• Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Quality Management).
• 10-15 years of experience in quality and regulatory roles, with at least 5 years in a senior or executive regulatory role
• Onsite presence in Raleigh NC office minimum 3 days per week
• Strong leadership, communication, and problem-solving skills.
• Direct experience working with the FDA and submission of 510(k)s
• Ability to work effectively in a fast-paced, dynamic environment
  
  

Preferred Experience & Education

• Experience in the Software as a Service business.
• Healthcare, or related, Industry experience.
• Experience with mergers and acquisitions.
• Knowledge and experience in the EU and UK markets, including familiarity with regulatory requirements and industry standards.
  
  

Supervisory Responsibilities

• Oversee the QARA department, including Risk Management, Internal Audit, Regulatory reporting, and quality analysts.
• Team Leadership: Experience in leading and managing QARA teams, including hiring, training, and mentoring team members. This involves setting performance goals, conducting performance reviews, and fostering a positive team culture
• Ensure the QARA team and extended teams operate efficiently and effectively.
  
  

Benefits

Our benefits are designed to help you move forward in your career, and in areas of your life outside of work. From health and wellness benefits, 401 (k) Savings Plan, stock incentive programs, paid time off, parental leave, and tuition assistance, we've got you covered with our total rewards package. For part-timers, your coverage will vary as you may be eligible for some of these benefits depending on your individual circumstances.

The pay range for a candidate selected for this position is generally within the range of $180,000 and $220,000 base salary. The successful candidate’s actual pay will be based on various factors, such as work location, qualifications, and experience, therefore the actual base salary may be above or below this range.

Clinisys Commitment to Equal Opportunity

Clinisys is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.

General Guidance

This job description is meant to provide an accurate depiction of tasks and accountabilities that are most often associated with this role. While we strive to provide an accurate depiction, nothing in this description restricts the company from changing, reassigning, expanding or reducing scope of accountabilities and is subject to change at any time.