Director of Quality and Regulatory Affairs – (San Diego, CA)

  • Job Details

  • Job Status: Closed
  • Posted On: February 1, 2018
  • Job Category: Engineering
  • Position Type: Full Time
  • Location: San Diego, CA
  • Desired Experience: 10 + Years
  • Desired Education: Bachelors
  • Compensation:
  • Travel: Regional
  • Relocation:

We are working with a client looking to hire a Director of Quality and Regulatory Affairs.

The Location:  The position will be located in San Diego, CA and reports to the SVP of Quality and Regulatory Affairs.

The Position: 

Leads company-wide Quality Assurance and Regulatory Affairs activities to provide functional support for product development and commercialization. Assures regulatory compliance and quality assurance functions required to develop accurate specifications, service, and delivery of product to our customers.  Manages regulatory elements of development schedules, personnel, resources and continuous improvement efforts to achieve efficient product creation and effective transfer of manufacturing through final product release. Evaluates and controls vendor reliability of goods and services.  Must have excellent Quality Assurance, Regulatory Affairs, P&L responsibility, leadership skills, and management experience.

 

Responsibilities:

  • Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacture of medical products in various categories, including Class I and Class 2 medical devices and related components.
  • Develops the product/organizational regulatory and quality assurance strategies including filings and submission types.
  • Prepares documentation and submits regulatory filings including 510k submissions, Device Master files, technical files, and post market surveillance.
  • Responsible for performing all duties in compliance with FDA’s Quality Systems Regulations, GMP’s, [S013485, Canadian Medical Device Regulations, Medical Device Directive 93/42/EEC (and all applicable amendments), AMM1 Sterilization Standards, OSHA, EPA, and other international, federal, state, and local regulatory agencies.
  • Assures validation and compliance of contract manufacturing and sterilization facilities.
  • Evaluates and provides for audits, corrective actions, and compliance verification of internal and external quality systems and their functions.
  • Provides the quality engineering function assuring that products meet their intended use through risk assessment, control  plans, product specification, continuous evaluation, and data analysis.
  • Refines and implements quality product process plans and systems.
  • Investigates, prepares, and maintains records of customer complaints, MDR vigilance/assessment/reporting, and enacting effective corrective actions.
  • Conducts on-site audits of various business unit product and processes. Provides pertinent information to other personnel and departments as necessary.
  • Hosts regulatory agency audits as required.
  • Prepares and presents organizational performance and technical information to the management team and associates.
  • Directs technical and administrative personnel engaged in quality assurance activities.
  • Reviews and controls documents, designs, and associated changes.
  • Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualification, first article evaluations, and other quality related subjects.
  • Develops and maintains an effective organization through selection, training, compensation, and motivation of personnel.
  • Provides company-wide education and guidance in quality/regulatory sciences.
  • Represents the company as the Quality and Regulatory expert internally and externally.
  • Acts as the quality/regulatory representative on new product introduction teams.
  • Assists with special projects as assigned.

 

Requirements: 

 

  • BS Degree in engineering, science, or related technical field with significant training and/or experience Quality & Regulatory Affairs. Advanced degree desirable.
  • Minimum 7-10 years experience (3-5 years in a management capacity) related to implementation of Quality/Regulatory with strong medical device product development and manufacturing experience covering several specialties including device registrations, quality systems requirements, new product development, design controls, and direct interaction with domestic and international regulatory bodies.
  • Must also be familiar with Product sterilization, FDA: CFR, ISO I 3485, ISO 14971, and CMDCAS systems/certifications. Safe Medical Devices Act including Design Control, Complaint processes Clinical, Environmental, and Document Control systems.
  • Must have a good understanding of blueprint reading, geometric dimensioning/tolerancing practices, and statistical quality concepts.
  • Be familiar with design of experiment practices.
  • Must have good supervisory experience, excellent communication, and interpersonal skills.
  • Must be detail oriented, organized, flexible, and can practically apply the quality sciences as a value-add to the organization.

 

Soft Skill Requirements

Education/Language Ability:

Ability to read, analyze, and interpret the most complex documents in English. Ability to respond effectively to the most sensitive inquires or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or associates.

 

Mathematical Ability:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

 

Reasoning Ability:

Ability to define problems, collect data, establish 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:

Must be proficient in Microsoft Office software to include Microsoft Project and Visio Mini-tab or like statistical software desirable.

 

The Compensation:  Compensation is commensurate with experience.  The company also provides excellent benefits, has a matching 401K plan, a quarterly bonus program and growth opportunities.

 

** Candidate must be a US citizen or green card holder **

 

Preference for local candidates or someone who has ties to the area

 

If you, or someone you know, may be interested and qualified for this position, please forward your resume and letter of interest

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