Director Of Regulatory Affairs / Quality Assurance

We are a leading medical device manufacturer seeking a highly skilled and experienced professional to join our team as the Director of Regulatory. As a key leadership role, this position requires a seasoned regulatory expert with a proven track record in FDA and 510(k) audits. The ideal candidate will bring extensive knowledge of Regulatory compliance, particularly in the context of medical devices, along with a solid background in ISO 13485 standards. In addition to regulatory expertise, successful candidates should possess strong management skills to lead and guide a dedicated regulatory team. If you are a results-driven regulatory professional with a keen understanding of FDA regulations, 510(k) processes, ISO 13485 standards, and proven management experience, we invite you to apply for this pivotal role in our dynamic and innovative organization.

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. The Senior Director of QA/RA will also be responsible for planning and implementing an effective internal audit program of all company 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.

Responsibilities:

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.

Requirements:

• 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.