SVP, Regulatory Affairs and Quality Assurance

Drive; Port Washington (NY); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading company in medical products is seeking a Senior Vice President of Quality Assurance & Regulatory Affairs. This role involves overseeing quality and regulatory compliance in both domestic and international operations, ensuring alignment with strategic corporate objectives. Ideal candidates will have relevant leadership experience and certifications in quality management.

Benefits

Competitive Benefits

Paid Time Off

401(k) Savings Plan

Qualifications

• Proven ability to analyze regulatory and quality trends in the medical devices sector.
• Ability to foster cross-departmental collaboration for compliance.
• Experience managing budgetary commitments and quality teams.

Responsibilities

• Oversee all quality assurance, regulatory activities for global operations.
• Maintain compliance with regulatory standards; manage QA/RA teams.
• Serve as point of contact for FDA and manage regulatory audits.

Skills

Leadership

Communications

Regulatory Knowledge

Analytical Skills

Education

Bachelor’s or Master’s degree in Engineering, Science, Quality, or Manufacturing areas

Certified Quality Manager (ASQ)

Certified Quality Engineer (ASQ)

Certified Quality Auditor (ASQ)

Regulatory Affairs Certification (RAPS)

Tools

ETQ electronic Quality Management System

Job description

Who is Drive DeVilbiss…

Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 100 countries around the world.

“Leading the World with Innovative Healthcare Solutions that Enhance Lives”

Summary (Major Purpose of the Role):

Responsible for quality operations, systems, and regulatory affairs across the Company, including corporate headquarters as well as domestic and international manufacturing sites and distribution centers. Transformational leader, strategic thinker, skilled communicator, team builder, and adept negotiator who blends expertise in global regulatory affairs and quality management with exceptional skills in business development and operations management. Proven ability to analyze regulatory and quality trends, products, and services, and develop and deploy solutions that continuously improve product quality, regulatory compliance and competitive performance, while aligning with corporate objectives and maintaining budgetary commitments.

Main Activities/Responsibilities:

The SVP of Quality Assurance & Regulatory Affairs is responsible for all quality and regulatory activities for the Company’s global operations importing, manufacturing, approval, registration and listing as well as distributing Class I and II durable medical equipment and respiratory products. Maintains oversight of the Company’s regulatory program and global Quality Management System and ensures compliance with all applicable regulatory standards. Manages the QA/RA team, including Senior Director and Director-level heads of Quality Assurance, Regulatory Affairs, Quality Engineering, Quality Control and Purchasing Control. Reviews and maintains existing systems and creates and implements new systems where required. Oversight of alignment of all sites, including corporate headquarters, acquired properties, and domestic and international manufacturing sites and distribution centers, to the Company’s global QMS. Fosters a culture of quality and regulatory awareness and teamwork.

• Continuous improvement and maintenance of existing Quality Management System, including creation and implementation of new policies and procedures where required; measurement, analysis, and trending; training; and management review.
• Partner closely with other members; build excellent working relationships across departments to maintain a culture of quality and regulatory awareness, cooperation, and solution-oriented focus.
• Maintain thorough and current knowledge of all applicable domestic and international regulatory standards; provide technical leadership and vision by interpreting regulatory initiatives and mandates while uncovering emerging regulatory trends.
• Serve as the point of contact for FDA and comparable international regulatory agencies, successfully manage regulatory audits and facility inspections, and devise and implement plans to remediate any adverse findings effectively and efficiently.
• Oversee all quality assurance, quality engineering and purchasing control activities, including document control, drafting and validation; supplier quality control; testing; investigation; etc.
• Oversee compliance with international medical device regulations regarding complaint handling, adverse event reporting and analysis.
• Oversee all domestic and international quality control activities, including inspections in Asia and all US distribution centers.
• Oversee all regulatory and foreign registration requirements, including state licensing and labeling.
• Oversee purchasing control activities, including quality agreements and supplier assessments.
• Develop and oversee operating and capital expense budgets for the QA/RA function.
• Manage development of technical requirements of supply and quality agreements and other external contracts.
• Travel required (approximately 10%) to US locations and properties, as well as international sites.

Competencies:

• Success in this role requires a leader that will become immersed in the day-to-day tactical details and is willing to roll up their sleeves and participate in execution of goals, objectives and initiatives.
• Strong working knowledge of 21 CFR 820, ISO 13485, MDSAP, UK Medical Device regulations, EU Medical Device regulations, CE Mark registration and other domestic and international regulatory standards as applied to Class I and II devices.
• Develop strategies to obtain FDA and international regulatory approvals of marketing applications in the US and around the world.
• Review and interpret regulatory rules as they relate to company procedures, engineering testing, and documentation and ensure that they are communicated through company policies and procedures.
• Oversee the review and approval of changes to manufacturing processes and products to ensure compliance with US and international requirements.
• Establish effective communication with executives and managers to ensure that company objectives and regulatory requirements are met.
• Enhance and sustain positive relationships with the FDA and other international regulatory agencies and notified bodies.
• Ability to facilitate interaction and cooperation between QA/RA and other departments to mitigate risk and maintain alignment of goals.
• Ability to directly interact with government officials and investigators in a cooperative and productive manner.
• Ability to develop and maintain excellent interpersonal relationships and proactively manage a large, cross-functional team of personnel in several different locations.
• Working knowledge of etq electronic Quality Management System.

Reporting Relationships and Supervision:

Direct management of all Quality and Regulatory subdivision heads, including Quality Assurance, Regulatory Affairs, Quality Engineering, Quality Control, and Purchasing Control.

Education and Experience:

• Bachelor’s or Master’s degree in Engineering, Science, Quality, or Manufacturing areas
• Certified Quality Manager (ASQ), Certified Quality Engineer (ASQ), Certified Quality Auditor (ASQ), Regulatory Affairs Certification (RAPS), Lean Manufacturing Leadership experience preferred.

Why Apply to Drive DeVilbiss…

Competitive Benefits, Paid Time Off, 401(k) Savings Plan

“Drive DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive DeVilbiss strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive DeVilbiss complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.”