Manager, Regulatory Affairs and Quality Affairs

SUMMARY Ansh Labs is hiring a Manager, Regulatory Affairs & Quality Assurance. The qualified candidate develops, coordinates, and implements quality management programs required for the development, approval and successful manufacture of products. Leads the organization through the Quality System Regulation (21 CFR 820), IVD Directive 98/79 EC, the European In-Vitro Diagnostic Regulation (IVDR) (2017/746) and ISO 13485. Monitors manufacturing, development, quality, and regulatory processes to ensure conformance and compliance with all FDA and applicable international regulations at Ansh Labs. Executes regulatory activities according to project plans to assure new products meet submission, approval, and commercial launch goals. Related activities include compiling and writing FDA and IVDR reports as well as coordinating the completion of technical file requirements across multiple departments. Leads domestic and international product registrations working directly with local customers and distributors. Manages corporate document control program and systems. ESSENTIAL JOB DUTIES Oversees the Company Quality Management System and Regulatory policies, procedures, and processes to ensure they are compliant to relevant requirements including, 21 CFR Part 820, IVD Directive 98/79 EC, IVDR 2017/746, as well as ISO 13485:2016 and other relevant international regulations. Serves as the Company Quality Management Representative and Person Responsible for Regulatory Compliance (PRRC), including representing the Quality Assurance and Regulatory department on project teams and audits. Manages activities associated with the Company’s CAPA, complaints, and nonconformance review processes. Develops and implements global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products through all phases of product life-cycle. Provides direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control in domestic and international markets. Drives clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of diagnostic products by relevant regulatory health authorities. Participates in preparation, review, and approval of key IVD regulatory submissions and certifications with US and international health authorities including 510(k)s, EU Notified Body certifications, etc. Negotiates directly with relevant Quality and Regulatory authorities to obtain and to maintain product clearances. Ensures international product distribution activities are compliant with applicable regulatory requirements Leads activities associated with post market surveillance, vigilance, adverse events, medical device reportable events and product recall activities, including notifications, corrections, and removals in international markets, if any. Manages internal and third-party audits, including FDA, EU Notified Body and vendors. Assesses impact of relevant regulations on IVD product development, registration, and commercialization activities. Other duties as assigned. QUALIFICATIONS · Bachelors/Masters in Biotech/related field. EXPERIENCE 3-5 years of experience working in a Regulatory or Quality position with a minimum of 2-3 years at a medical device company, preferably IVD. Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical and life-science IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations. Experience working with US FDA Quality System Regulations 21 CFR 820, ISO 13485, and EU (CE) Regulations (IVDD/IVDR) is essential. Demonstrated communication and human relation skills. · Solid scientific analytical evaluation skills. · Ability to work well within cross-functional teams. · Technical writing ability a MUST. · Proficient using Word and Excel applications and Windows operating system. · Must be able to work effectively in a fast-paced, team-oriented environment. · Ability to work independently with minimal supervision. · Demonstrated cross-functional teamwork skills. · Self-starting, detail oriented, and ability to focus on task at hand. · Well-developed English written and verbal communication skills.