Sr. Director Of Quality Assurance And Regulatory Affairs

Company Summary

Dynarex is a leading medical supply company providing premium medical products and durable medical equipment at exceptional value — for an unparalleled one-stop shopping experience. Dynarex’s guiding principle “We Care Like Family” exemplifies the outstanding customer service that sets the company apart in the marketplace. Founded in 1967, we have distribution centers in Middletown, NY, Florida, Arkansas, Ohio, and Arizona and distributor partners in all 50 states as well as Canada, the Caribbean Islands, Central America, South America, and the Middle East.

Position Scope

The role of the Senior Director of QA/RA is highly technical with specific requirements. The ideal candidate will provide compliance and quality management program leadership and will act as the point person during external ISO 13485/MDSAP annual audits. In conjunction with other internal departments, the QA Director will implement a systematic approach to quality management to ensure adherence to GMP requirements across all Dynarex projects. The Senior Director of QA/RA will also be responsible for planning and implementing an effective internal audit program of all Dynarex processes and procedures. The position calls for the effective management of the RA and QA departments and their members with responsibilities for all quality systems, direct collaboration with the new product development team, overseeing all Regulatory Affairs including regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, and Canadian Medical Device Regulations.

What your impact will look like at Dynarex

Regulatory Compliance:

• Stay abreast of regulatory requirements and changes, ensuring the organization's compliance with local, national, and international regulations.
• Develop and execute regulatory strategies to facilitate product approvals and certifications.
• Develop, design, and enhance regulatory initiatives to facilitate overall regulatory compliance, preparation of 510(k) premarket notifications, and submissions.
• Oversight of 21 CFR 820.
• Preparation of responses to Regulatory authorities’ supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.
• Provide regulatory input to ensure activities follow all appropriate regulations and standards, including FDA, ISO 13485:2003, and CMDR.
• Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company and present information as needed.

Quality Management:

• Establish and maintain a robust quality management system, including policies, procedures, and documentation to ensure product quality,
• Lead quality improvement initiatives and drive a continuous improvement mindset throughout the organization.
• Ensure the familiarity of all members of team with correct formats/procedures for labeling. Monitor labeling regulations, external environment, and proposed US regulations/guidance.
• Provide regulatory oversight of changes in manufacturing facilities, processes, procedures, and testing methods.
• Direct internal and external compliance programs, audits, and site inspections by federal and international regulatory agencies. Write and update departmental Standard Operating Procedures.

Team Leadership and Development:

• Lead a high-performing team, providing guidance, mentorship, and professional development opportunities.
• Forster a collaborative and inclusive work environment.

You will love this job if you have:

· Bachelor’s Degree in a related field, master’s preferred

· ISO 13485 Auditor Certification a plus.

• A minimum of 5 years of regulatory and Quality Assurance.
• An excellent understanding of FDA, FDA QSR 820, GMP’s, drug cGMP, International ISO Standards, ISO 13485, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations & Canadian Submissions.
• Experience in 510K preparation and submission.
• Experience in USFDA and ISO auditing and the ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Premarket Approval Applications, (PMAs), New Drug Applications (NDA).
• Full knowledge of 21 CFR 820.
• Familiarity with OTC pharm registration and submission.

Necessary competencies:

• Experience with VEEVA
• Proficiency with Microsoft Office Suite 365.
• Excellent organizational skills.
• Strong writing, project management and communication skills.
• Ability to multitask, prioritize and manage many projects at once.
• Self-motivation with the ability to take initiative in a challenging, fast-paced environment.
• Ability to assume responsibility and work independently with little or no supervision.
• Problem-solving skills, Adaptability, Attention to detail, Time management, Multitasking, Team player & the ability to manage and motivate team members.

We care like family, come join a world class progressive organization with a sustainable mission.

For candidates meeting all the requirements, the expected base salary is $160,000 to $185,000 per year. The range provided is the salary that Dynarex Corporation in good faith believes at the time of this posting that it is willing to pay for the advertised position. Exact compensation will be determined based on individual candidate qualifications and experience. Our benefits package includes coverage options for medical, dental, vision, prescription drug, health savings account, 401K with a match, EAP, Basic Term Life insurance, paid time off, holidays, plus various opportunities for professional development.

Disclaimers:

• This job description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required by an employee.

Job Type: Full-time

Pay: $160,000.00 - $185,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Work Location: In person