Job description

The Assistant Company has been hired by a leading Las Vegas manufacturer of products in the personal health and wellness category to find a Quality Control/Regulatory Manager. Their 3O+ year old established national brand has full chain-wide distribution in all the big box stores, large drug store chains, grocery chains and on Amazon. In additions to its own brands, this company manufacturers well over 100 private label brands. The facility/laboratory is fully licensed and accredited by the FDA and other government agencies. Please read entire ad before applying.

Job Responsibilities:

· Organizes and directs all regulatory and quality aspects in the development, design and manufacturing of medical and cosmetic technologies.

· Maintains quality standards by approving production/manufacturing, R&D process, and implementation and maintains of the Domestic and International Standards.

Job Duties:

· Maintain and directs worldwide regulatory activities associated with the Quality Management System (QMS) with compliance to international and domestic regulations.

· Manages the QMS of the company as its Quality Management Representative.

· Act as the liaison with external parties on matters relating to the QMS.

· Recruit and maintain strong regulatory and quality team capable of addressing operations.

· Directs all corporate QSR/ISO compliance activities and oversees all internal audits, complaint processing, and medical device reporting (e.g. MDR, Vigilance and Mandatory reporting processes).

· Develops and follows through on Regulatory and Quality initiatives.

· Develop and implement programs to improve quality and compliance.

· Introduce, develop, maintain, and periodically update the Quality Procedures, Manual, Objectives and Philosophies.

· Develops strategies and implements plans to obtain FDA Approvals, CE/UKCA mark, ANSI/305 Organic product and other regulatory approvals.

· Defines and establishes policies and procedures according to regulatory requirements in cooperation with the appropriate company senior managers.

· Assures inspections and audits conducted by State and Federal regulatory agencies are managed professionally and effectively.

· Keeps abreast of new and emerging regulatory laws and regulations as they impact the business and operations of the company.

· Accountable for submission of quality metrics.

· Perform additional duties as required.

Supervisory Responsibilities:

Supervise/manage/direct the selection, training, development, appraisal and work assignments of personnel. Employees directly supervised by this job: 5-10 employees.

Supervision Received

General Direction: receive very general guidance with respect to overall objectives; work is usually quite independent of others: operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

Other Duties and Responsibilities:

· Other duties may be assigned.

· Prepares, compiles and files product approval submissions and other regulatory documents as required and negotiates directly with regulatory authorities regarding company’s filings.

· Advises corporate personnel regarding the development and implementation of regulatory and quality strategies and potential areas of concerns.

· Periodically communicates with representatives of the FDA and other regulatory agencies as needed to maintain rapport and advance development projects.

· Coordinates with other departments, corporate or marketing partners, and international offices to achieve project goals.

· Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.

· Participate in proactive team efforts to achieve departmental and company goals.

· Provide leadership to others through example and sharing of knowledge/skill.

· Accomplishes all tasks as appropriately assigned or requested.

Competency:

To perform the job successfully and demonstrate the following competencies:

· Problem Solving – Gathers and analyzes information skillfully.

· Interpersonal – Maintains confidentiality.

· Oral Communication – Listens and obtains clarification.

· Written Communication – Varies writing style to meet needs.

· Attendance/Punctuality – Is consistently at work and on time.

· Dependability – Follows instructions, responds to management direction.

· Planning/Organizing – Organizes or schedules other people and their tasks.

· Professionalism – Treats others with respect and consideration regardless of their status or position.

· Quality – Monitors own work to ensure quality.

· Quantity - Works quickly.

Qualifications & Education:

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

Education/Experience:

· 10 years’ experience in medical industry and/or quality programs.

· Prefer BA/BS degree in Engineering or a related discipline.

· Minimum 10 years’ experience in performing QA/RA activities in an FDA/International regulated medical device environment.

· Must have experience in auditing documents systems, regulatory procedures and policies.

· Prefer expertise in FDA negotiation, ISO 13485 and regulatory strategies development with demonstrated experience in interacting with U.S. and global regulatory agencies.

Communication Skills:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to top management, public groups and/or boards of directors.

Mathematical Skills:

Ability to calculate figures and amounts such as, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability:

Ability to define problems, collects data, establishes facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

Proficient personal computer skills including electronic mail, record keeping, routine database activity, work processing, spreadsheet, graphics (i.e. Microsoft Office, Excel, Access, etc.)

Certificates and Licenses:

Certifications of FDA cGMP / QSR training or ISO 9001 or 13485 is optional.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

Job Type: Full-time

Pay: Up to $125,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Relocation assistance

Schedule:

• Monday to Friday

Application Question(s):

• Do you have a BA/BS degree in Engineering or a related discipline?
• Do you have minimum 10 years' experience in performing QA/RA activities in an FDA/international regulated medical device environment?
• Do you have the required ISO 13485?
• Do you have expertise in FDA negotiation and regulatory strategies development with demonstrated experience interacting with US and global regulatory agencies?

Work Location: One location

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