Under general direction, will oversee Regulatory, Quality Assurance & Compliance 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.
- Coordinate activities in quality assurance, product return, 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.
- Plan and direct the organization’s Quality Systems and Regulatory policies, objectives, and initiatives.
- Plan, direct and document the review of the suitability, effectiveness and adequacy of the organization’s Quality System.
- Manage the Quality Assurance Program in accordance with FDA Quality System Regulations (QSRs) and ISO 13485 Quality Systems. Serve as designated Management Representative for the Company.
- Ensure that quality system requirements are maintained and report to Management with Executive Responsibility on the performance of the Quality System.
- Develop, implement and maintain processes used in the design, manufacture, and service of devices and assure that they are adequate, in support of and aligned with company objectives and in full compliance with regulatory requirements.
- Recommend and approve changes to the Quality System as necessary to ensure compliance with FDA/ISO/EN/MDD/CMDR & CE marking requirements.
- Lead, direct, coordinate and maintain the process for creation and maintenance of product design dossier/technical files.
- 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.
- Direct and prepare regulatory documentation for submission to regulatory agencies inside the U.S. to achieve product registrations. Manage/coordinate domestic and international submissions, compliance efforts, labeling review, and product development as required.
- Prepare reports and summaries such as regulatory positions, statements, and interpretive abstracts of reports to be submitted to the FDA.
- Provide leadership in establishing regulatory policies and procedures in full compliance with FDA and Canadian regulations.
- Provide leadership for timely and effective submissions leading to product approvals for marketing in the U.S. and Canada.
- Preserve the rights of the Corporation when acting as liaison between the Corporation and the FDA.
- Interact with local, State, Federal and international regulatory agencies.
- 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.
- Analyze and monitor department costs.
- Initiate personnel actions, including employee hires, promotions, transfers, and discharges.
- Create and present employee evaluations, subject to the approval of the CAO.
- Assesses subordinate employee training needs and conduct or recommend training as necessary.
- Administer employee disciplinary actions as the situation requires.
- Develop and maintain productive and effective relationships with subordinates, peers, and superiors.
- Demonstrate a high standard of work ethics and professionalism to subordinates, peers, and superiors at all times.
- Represent the company in a positive and supportive manner at all times.
- 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 regulated by FDA and safeguard restricted, confidential, private or personal information or 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.
Bachelor’s degree (B.S.) from four-year college or university; and ten years as managerial experience in quality assurance and/or regulatory experience in manufacturing medical devices; or equivalent combination of education and experience. Advanced degree and experience in the medical device manufacturing quality assurance area preferred.
Lompoc, California, United States