Director, Quality and Regulatory Affairs

Notice: MCRA's Talent Solutions division works to unite top talent with opportunities on our clients' teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).Primary Roles:Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groupsServes as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organizationResponsibilities:Quality Systems Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certificationResponsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizationsActs as lead in all product complaint and recall campaigns.Responsible for interfacing with and following up with any Customers regarding complaintsResponsible for Supplier Quality assurance programResponsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.Leads the Management Review processQuality EngineeringEnsures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirementsEnsures all device history records are complete and reviewed prior to release of productAssist suppliers by providing information to enable process improvementsEnsure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDRSupports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processesLeads Risk Management and Post-Market Surveillance activitiesRegulatory AffairsDevelop and implement global regulatory and compliance strategies to:Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirementOptimize and focus on quality during the design and change control processes for both new and existing products;Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.Responsible for the CE Mark approval process for all products, and Technical File generation and maintenanceResponsible for writing Letters to File as requiredParticipates in the development and writing of 510(k) submissions with the management team utilizing external resources as requiredResponsible for external agency reportingEducation:Bachelor's Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.Experience/ Skills:Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metricsDemonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend reportHas experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvementAble to solve complex quality, technical, managerial or budgeting problemsReadily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environmentWorking knowledge of data acquisition, analysis and statistical softwareDemonstrated ability to manage multiple projects and technical personnel simultaneouslySuccessful oral and written communication skills, business acumen and assertive decision-making abilityExcellent computer skills, including MS Office proficiencyNOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.