Head of Quality & Regulatory Affairs - Autoimmunity

Werfen•San Diego, CA

2d•$240,000 - $280,000•Onsite

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary The Head of Quality and Regulatory Affairs is responsible for developing, coordinating and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of Autoimmunity products. Responsible for interacting, influencing and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for all regulatory strategies, regulatory compliance, quality systems programs and quality training; also serves as the Management Representative, Person Responsible for Regulatory Compliance (PRRC per IVDR) and HIPAA Privacy Officer. In conjunction with the CEO, creates policies to maintain compliance with legal and regulatory requirements. Provides leadership and development to assigned teams and staff. Serves as a member of the Autoimmunity Executive Team.

Requirements

Bachelor’s degree life sciences or related field required, advanced degree in Quality or Regulatory strongly preferred.
At least ten (10) years Quality & Regulatory corporate leadership experience, within the medical device industry required.
Demonstrated experience leading organizational change required, within a regulated industry.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required.
Excellent knowledge of Quality Systems Regulations, Product Change Requests and ISO regulations as they apply to device manufacturing required.
Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required.
Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required.
Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required.
Track record of success at building and leading high performing, complex teams.

Nice To Haves

advanced degree in Quality or Regulatory strongly preferred.

Responsibilities

Works closely with the COO, provides information on the status of product quality, customer satisfaction, opportunities for quality improvement, process simplification and the capability of the Quality System.
Ensures processes and procedures are in place to investigate and resolve customer complaints to the customer’s satisfaction in a timely manner. Ensures all root causes of customer dissatisfaction are determined and that processes are improved to prevent reoccurrence.
Ensures total customer satisfaction is a priority of employees by working closely with the management team and through personal leadership skills.
Ensures timely completion of QC product testing and QA product release dispositions.
Ensures appropriate stability studies are conducted to support new products, shelf life extensions, and any additional stability studies for international registration.
Provides leadership for special projects in Quality Assurance, Quality Control, Complaint Handling and Regulatory Affairs.
Oversees preparation of technical dossiers for CE Mark product, regulatory Canadian submissions and other international registration documentation and works in partnership with distributors and/or affiliates by providing to them appropriate documentation to obtain international product registrations.
Handles any regulatory reporting needs such as product corrections, removals, recalls and MDR Reporting and vigilance activities.
Manages the quality and regulatory staff and departmental resource needs. This includes but is not limited to, interviewing, hiring and training employees; planning, assigning and supervising work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Creates and leads high-performing, innovative, management teams that attracts, recruits, develops and retains exceptional staff.
Provides leadership and management to ensure that the mission and core values of the company are put into place.
Creates a culture of compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality Systems regulations (QSRs), as well as applicable Environmental Health & Safety, Human Resources, HIPPA and other regulatory and administrative policies.
Reflects the Werfen’s Values as a role model to employees, customers, and business partners.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.