Director, Quality Assurance & Regulatory Affa

Objective

Under general direction, will oversee the Quality Assurance & Regulatory departments and develop and implement department goals, objectives, and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA and applicable international regulatory bodies and/or standards.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

1. Coordinate activities in quality assurance, product returns, and regulatory to ensure compliance with all applicable regulatory requirements and achievement of company objectives as well as resolve problems; work with other departments to accomplish the same.
2. Plan and direct the organization’s Quality Systems and Regulatory policies, objectives, and initiatives.
3. Plan, direct and document the review of the suitability, effectiveness and adequacy of the organization’s Quality System.
4. Manage the Quality Assurance Program in accordance with cGMP, FDA Quality System Regulations (QSRs) and ISO 13485 Quality Systems for the Company’s products, including but not limited to its medical devices, manufactured drugs, private labeled drugs and cosmetics.
5. Serve as the Company’s Management Representative and Person Responsible for Regulatory Compliance (PRRC), and be the lead contact for all regulatory agencies, notified bodies, and international representatives, including but not limited to MDSAP and EU-MDD/MDR countries.
6. Ensure that quality system requirements are maintained and report to Management with Executive Responsibility on the performance of the Quality System.
7. Execute Management Reviews and Annual Product Reviews in accordance with requirements and the Company’s Quality Management system.
8. Develop, implement and maintain processes used in the design, manufacture, and service of Medical Devices, Drugs and Cosmetics and assure that they are adequate, in support of and aligned with company objectives and in full compliance with regulatory requirements.
9. Recommend and approve changes to the Quality System as necessary to ensure compliance with FDA/ISO/EN/MDD/CMDR & CE marking requirements.
10. Lead, direct, coordinate and maintain the process for creation and maintenance of product design dossier/technical files.
11. Ensure that all Drug products have the appropriate development history documentation, comprehensive Master Production Records and that Batch Production Records are properly maintained.
12. Communicate changes to the Quality System and/or to product requirements, defined in the Design History File, Design Dossier, and/or Technical Files to the applicable Notified Body.
13. Direct and prepare regulatory documentation for submission to regulatory agencies inside and outside the United States, specifically key International markets including but not limited to Canada, the EU, Asia Pacific, the Middle East, Latin America and Australia to achieve product registrations. Manage/coordinate domestic and international submissions, compliance efforts, labeling review, and product development as required.
14. Prepare reports and summaries such as regulatory positions, statements, and interpretive abstracts of reports to be submitted to the FDA.
15. Provide leadership in establishing regulatory policies and procedures in full compliance with FDA and Canadian regulations.
16. Provide leadership for timely and effective submissions leading to product approvals for marketing in the U.S. the E.U., Canada and other key markets.
17. Serve as the primary point of contact for interactions with the FDA and other pertinent regulatory agencies in the U.S. and lead the Company’s response to all auditing activities by these agencies.
18. Preserve the rights of the Corporation when acting as liaison between the Corporation and the FDA.
19. Maintain verified accredited wholesale drug distribution certification (VAWD) in all 50 states within the U.S.
20. Ensure that the Company’s portfolio of Medical Devices, Drugs, and Cosmetics are compliant with all applicable laws for manufacturing, marketing, sales and or distribution in the relevant global markets.
21. Interact with local, State, Federal and international regulatory agencies as needed.
22. Keep abreast of current national and international regulations relative to the lawful sale and distribution of products. Alert executive management to any conditions required for the continued operation of the Company.
23. Monitor changes in standards across all key markets including the U.S., the E.U., Canada and other territories.
24. Analyze and monitor department costs.
25. Initiate personnel actions, including employee hires, promotions, transfers, and discharges.
26. Create and present employee evaluations, subject to the approval of the COO.
27. Assesses subordinate employee training needs and conduct or recommend training as necessary.
28. Administer employee disciplinary actions as the situation requires.
29. Develop and maintain productive and effective relationships with subordinates, peers, and superiors.
30. Demonstrate a high standard of work ethics and professionalism to subordinates, peers, and superiors at all times.
31. Represent the company in a positive and supportive manner at all times.

Additional Duties and Responsibilities include the following. Other duties may be assigned.

1. Travel to attend professional meetings and seminars.

2. Maintain supplementary files on supervised employees.

3. Process time reports and absence requests.

4. Review work reports, papers, and other records prepared by subordinate or other personnel for clarity, completeness, accuracy, and conformance with company policies and federal regulations.

5. Report on departmental activities to executive management.

6. Other projects as assigned.

Supervisory Responsibilities

Carries out supervisory responsibilities, if applicable, in accordance with the organization’s policies and applicable laws. Responsibilities include hiring; delegating and conducting training; assigning, reviewing, and approving work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education and/or Experience

Bachelor’s degree (B.S.) from four-year college or university; and ten years as a senior manager with quality assurance and/or regulatory experience in manufacturing medical devices and drugs; or equivalent combination of education and experience. Advanced degree and experience in the medical device and or drug manufacturing quality assurance area preferred. Experience with manufacturing to cGMP for drug products is required.

Qualifications

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Language Skills

Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write reports, business correspondence and policy and procedure manuals. Ability to make effective and persuasive speeches and presentations on controversial or complex topics. Ability to respond to questions or complaints from executive management, customers, international and domestic regulatory agencies, public groups, members of the business community, employees of the organization and to interact with diverse personalities and cultures.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to apply concepts of basic algebra and geometry.

Computer Skills

Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Certificates, Licenses, Registrations

None.

Knowledge, Skills, and Abilities

Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.

Knowledge of regulatory submissions (IDE, 510(k), etc.).

Ability to develop effective quality systems and regulatory strategies and programs.

Ability to demonstrate excellent organizational, leadership, reasoning, judgment, and interpersonal skills.

Ability to establish and maintain moderately complex documentation systems.

Ability to communicate effectively, orally and in writing, with many levels of employees of various disciplines within various departments, and all other internal and external contacts.

Ability to be flexible in changing daily workload priorities, as directed.

Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.

Ability to coordinate and implement multiple projects.

Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.

Ability to travel, including overnight stays.

Ability to administer a budget.

Ability to work under pressure against deadlines and within budget.

Ability to use MSWord, Excel, and PowerPoint and various office machines such as personal computer, FAX, copier and telephone.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to sit; talk and hear; use one or both hands to finger, handle or feel; use a simple grasp; and occasionally required to stand, walk, grasp with one or both hands; and to lift and/or move up to 10 lbs. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet.

The posted range for this position is $130,000-$160,000 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

DenMat offers a complete benefits package, including medical/dental/vision/Rx, Life, 401(k) with matching, 10 paid company holidays, vacation and sick time, bereavement, EAP, and employee discounts.

DenMat participates in E-Verify.

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.