Werfen North America · 23 hours ago
Sr. Director, Quality Assurance and Regulatory Affairs
Norcross, GA
Full-time
Onsite
Director/Executive
10+ years expWerfen North America is a family-owned, innovative leader in specialized diagnostics. The Sr. Director of Quality Assurance and Regulatory Affairs is responsible for overseeing the site Quality Management System and ensuring compliance with federal regulations, while also leading the Quality Assurance, Quality Control, and Regulatory Affairs organization.
Health CareManufacturing
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
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 acheive Werfen quality objectives
Qualification
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 North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America 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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase