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Werfen · 1 day ago

Sr. Director, Quality Assurance and Regulatory Affairs

US-GA-Norcross

Full-time

Onsite

Director/Executive

10+ years exp

Werfen is a growing, family-owned, innovative company that specializes in diagnostics in Hemostasis, Acute Care Diagnostics, and more. They are seeking a Sr. Director of Quality Assurance and Regulatory Affairs responsible for overseeing the site Quality Management System, ensuring compliance with regulations, and leading the Quality Assurance and Regulatory Affairs team.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Ensures that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, Regulation EU 2017/746, EN ISO 13485 standards and site Quality requirements

Act as the QA -RA representative of the site leadership team and, sponsoring Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations and directing GMP aspects of plant activities

Interfaces with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards

Responsible for the decision on acceptability and release of all site products

Organizational responsibilities include site Quality Assurance, Quality Control and Regulatory Affairs documentation, and regulatory inspection / customer audit liaison activities. Additional responsibilities include site department budget, hiring and development of personnel, and management of the Quality and RA organization

Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance

Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met

Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management

Responsible for the overall surveillance and operation success of assigned functions and for successfully integrating these activities with those of other major organizational segments

Serves as the site Management Representative and Person Responsible for Regulatory Compliance (PRRC), as defined by 21CFR part 820 the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746

Directs the risk management and design control strategy for the development and manufacture of new and existing Medical Device products

Acts independently, guided only by very broad company policies and objectives. Makes final decisions on administrative or operational issues affecting major segments or functional activities of the organization

Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, MDRs/Vigilance/FSCA/ complaint closure, etc.)

Ensures adequate training (and documentation) of employees within the departments listed above

Prepare, maintain and ensure adherence to departmental budgets

Report quality system performance measures to top management

Liason and support EU Authorized Representative to ensure compliance to EU regulation, regulatory correspondence, and maintenance of technical documentation

Partner with the site operations leader to meet quality and compliance objectives, design goals, and production targets

Interface with Werfen RA.QA collegues to achieve Werfen quality objectives

Qualification

Quality Management SystemRegulatory AffairsQuality AssuranceRegulatory ComplianceISO 13485CAPA SystemsFDA AuditsEU RegulationsLeadershipCommunicationTeam Management

Required

B.S Degree or equivalent in Science or Engineering

Minimum 10 years experience in a management capacity covering a span of responsibility within Quality Assurance and Regulatory Affairs within the IVD, Medical Device and/or biopharmaceutical industry

Demonstrated track record in successful US FDA, EU and ROW premarket audits/inspections and regulatory submission, including 510K and IVDR/MDR

Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 13485, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (10)

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2023 (10)

2022 (2)

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2020 (8)