Requirements: English
Company: Organogenesis
Region: Canton, Estados Unidos
**Job Description**:SUMMARY- -----Responsible for the generation, formatting, andpreparation/publishing or review of regulatorysubmissions or and related documentation for cellular-and tissue based biotechnology products. Develop andimplement efficient and effective regulatory strategiesto bring products to market, provide input andparticipate in product design and development teams.Gather and compile documentation to support assignedprojects and regulatory submissions to FDA andinternational authorities such as PMA submission,510(k)s, annual reports, device listings, designdossiers, technical files, international licenses, andstate business licenses. Participates in project teamsand may lead specific regulatory tasks, under theguidance of senior staff. Will also assist in thedevelopment of departmental procedures and maintainingregulatory compliance with applicable regulations.KEY RESPONSIBILITIES- ------------------- Advise technical and operational functions indetermination of the necessity for submissionpackages for FDA and other federal and internationalregulatory agencies for new product and productmodification registration/approval requirements.Participant on product development teams responsiblefor providing guidance on regulatory issues andprocedural recommendations for standard operatingprocedures and protocols.Define clear tactics to gain regulatoryclearance/approval in the US and global community.Responsible for filing necessary applications andhandling all government interactions pertaining tothe regulation process for products requiringgovernmental approval.Manage communications with relevant regulatoryauthorities and standards accrediting bodies (e.g.AATB)Assists in developing procedures to ensureregulatory compliance.Assists in the evaluation of change controldocuments for impact on submissions and filingrequirements.Collaborate with Quality Assurance to manage andensures regulatory compliance with 21 CFR, GMP/QSR,EMEA and Design Control programs and otherregulatory requirements as appropriate.Support internal and external audits includinginteractions with FDA auditorsParticipate in cross-functional teams and activitiessuch as product design and development, riskassessments, evaluation of quality events andnon-conformances, evaluation of change controls,validation and testing; determine impact onsubmissions and filing requirements.Ensure compliance with applicable tissue bankregulations and maintenance of tissue bank licensesand registrationsMaintain FDA and international device listings andestablishment registrationAssist with Regulatory Database development,organization and maintenance**Job Requirements**:PREFERRED EDUCATION AND EXPERIENCE- --------------------------------Bachelors degree or equivalent, preferably in ascientific or technical discipline. Minimum 2-5 yearsRegulatory Affairs experience in the medical industryand minimum 5 years in life sciences industry. Preferredexperience working with biotechnology-derived productsand experience with PMA and/or 510(k) required. Workingknowledge of FDA regulations required and familiaritywith relevant authorities and agencies preferred. Strongorganizational, interpersonal and written/verbalcommunication skills required. Experience with technicalaspects of product development and manufacturing.Work Requirements- ---------------This position may include extended periods of sittingeach day. This position also requires use of repetitivehand movement e.g. keyboard use for moderate or long- periods of time.