Overview

Report this job About the Job  Bionik, Inc. Job Description Title:  Manager, RegulatoryAffairs and QualityAssuranceReports to:Vice President, US OperationsLocation:  Boston, MA Ground floor opportunity for a mature, flexible,individualto help build world-classRegulatory and Quality functions for recently public company and pioneer in rehabilitation robotics.  Work at a senior level in a fast-paced setting with significant visibility and business impact.  Some travel to suppliers, customers and sales representatives may be required. Essential Functions Positioninvolves functions and corresponding responsibilities spanning company Quality Management System, product development process, and regulatory agencies with which the company interacts. Quality Management System responsibilities include: Serve as Quality Manager and Management Representative for Quality Management SystemMaintain and ensure the company quality system meets FDA, CE and other international medical device requirementsManage and maintain Quality Manualand Quality Operating ProceduresKeep company prepared for internal and external audits/inspectionsConduct and document internal auditsPrepare for and chair management reviewsRepresent the company at external audits/inspectionsEnsure that commitments to FDA andother regulatory bodies are met     With top management, establish company annual quality objectivesMaintain the company’s Approved Vendor ListEnsure test equipment is calibrated on the proper schedule and logs are maintainedDevelop and deliver training to ensure organization understands and embraces quality procedures and verify on-going complianceTrack status of and review Quality Management System records, including Engineering Change Orders (ECOs), Corrective and Preventive Actions (CAPAs), Customer Service,and Non-Conforming ProductsEnsure compliance with applicable regulations, standards, systems, procedures and practices Product Development Support responsibilities include: Attend and document Design Review, Risk Management, and other meetings required by the Quality System and ensure product development process complies with Quality System      CompileDesign History Files and Device Master RecordsEnsure that products, labels, user manualsand the like meetregulatory requirementsReview Verification and Validation plans, execution and final reportsAid in Usability testing, Clinical Evaluations, MDD Essential Requirements formsPrepare, assemble and submitregulatory documents (510(k), CE Technical Files, other international regulatory) as required Regulatoryresponsibilities include:Serve as main contact with company’s Notified Body, FDA and other regulatory agenciesInterface with company’s EC Authorized RepresentativeMaintain files of regulatory submissions and related communicationsMaintain FDA and other registrationsEnsure marketing, sales and other materials (e.g. labels) conformto regulatory requirementsDevelop strategies for regulatory submissions and compliance issuesReview findings from internal and external audits, help develop responses Qualifications Skills/attitudeOutstanding written and verbal communication skillsStrong attention to detailWorks well cross-functionally in matrix environment, good team player “I got it”, “can do” attitudeFlexible, hands on approach to problem solving, takes ownershipTact, poise and diplomacy in dealing with regulatory agencies, customers and other employeesSelf-starter who works with a sense of urgencyAdaptable and resourcefulGood knowledge of Microsoft Word and Excel Engineering experience a plus Education/experienceUndergraduate degreeMinimum 5 years experience managing Quality and Regulatory activities in an environment subject to FDA Quality System Regulations (21 CFR 820) and/or ISO 13485 requirements.Experience managing / coordinating documentation in a development environmentRAC certification and auditing experience in accordance with FDA QSR, ISO 13485 a plusKnowledge of FDA’s QSR, GMP’s, ISO13485, Medical Device Directive 93/42/EEC; ISO regulations/standards, including ISO 13485, 10993, 14971 Knowledge of US and international medical device regulatory requirements We appreciate your interest and will contact you if your skills match our needs.  Due to the large number of resumes we usually receive, we cannot to reply to each individually. Applicants and position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis. Bionik Laboratories is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Bionik Laboratories discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.1  Report