Regulatory Affairs Specialist jobs in Atlanta, GA

StimLabs is looking to hire a Senior Regulatory Affairs Specialist to join our Regulatory team. This role would report directly to our Chief Regulatory and Quality Officer. The ideal candidate has extensive experience partnering with R&D and marketing to review marketing materials for HCT/P and devices. Although this person does not have to work out of our Roswell, GA office, ideally this person would be able to come into the office a minimum of one day a week.

• Promotes culture of regulatory excellence within the organization by raising awareness for regulatory standards and compliance, plans and participates in regulatory education activities
• Plans and/or contributes to the development of regulatory affairs strategy and related infrastructure for new products
• Represents organization’s regulatory strategy when leading or contributing to various projects
• Leads various department activities and actively participates in daily Regulatory activities
• Designs, develops, and executes training programs to disseminate regulatory knowledge throughout the organization
• Member of StimLabs internal audit team and maintains qualification as a lead auditor as defined by StimLabs
• Carries out the interest, priority, and strategy of the Regulatory Affairs Department when Regulatory management or leadership is absent. 

• Represents department by carrying out organization’s regulatory strategy when reviewing labeling and promotional material review activities and provides regulatory support during claims substantiation according to applicable regulatory framework.
• Carry out all necessary regulatory filing updates, depending on applicable regulatory framework, based upon organization requests for changes to labeling or other factors that that may have FDA or regulatory body implications (e.g., premarket submission)
• Provide regulatory input to Product Development team to support the design of protocols and test plans that substantiate relevant claims for marketing collateral or regulatory submissions
• Provide regulatory support to Research and Development and Quality Control for test method development and validation in support of product development in accordance with applicable regulatory framework
• Support organization’s clinical efforts and designated team by drafting or reviewing Informed Consent documents, clinicaltrials.gov submissions, and supporting, authoring, and/or reviewing investigative brochures, clinical study protocols, report writing, and subsequent study publication as applicable
• Support clinical site evaluation and qualification, as applicable
• Maintain or provide leadership/carry out activities for all necessary state licensure/certifications, export certifications, and domestic and international product registrations, etc., as needed, to ensure no lapse in licensure, certification, or registration
• Provide leadership during development of regulatory submissions (e.g. RFD, 510(k), eSTAR, Q Submission, TRG, IND/CTA, BLA, RMAT, FOIA, etc.) and submission strategy, maintaining and submitting in a timely manner aligned with organizational goals/priorities
• Lead preparation for meetings with regulatory bodies and manage correspondence with regulatory agencies, as requested by management.  
• Maintain appropriate FDA establishment registration for all regulated products, providing periodic updates to registration or product listing, as needed
• Responsible for management of regulatory reporting activities including reportable Adverse Reactions, HCT/P Deviations, Recalls, Medical Device Reports, and any other applicable mandatory reporting as applicable to organization or as directed by management
• Represent Regulatory Affairs department in Change Control meetings to ensure applicable design elements are maintained and not deleted by the change, and to ensure that regulatory classification of the subject product/device is not impacted by the change, or if the regulatory classification is impacted by the change, that the appropriate regulatory justification is provided including submission of a new pre-marketing application, if necessary.
• Provide leadership and assistance with regulatory inspections before and after inspection
• Carry out, plan, and provide leadership in the application of risk management processes
• Under the direction of Management, correspond with regulatory agencies as required including set up and maintenance of Electronic Submissions Gateway (ESG), Customer Collaboration Portal (CDRH Portal), or any other method of transmitting information and corresponding with a regulatory agency.
• Responsible for requesting payment of any and all regulatory fees according to current regulatory requirements including establishment fees, accreditation fees or dues, or any applicable user fees
• Monitor evolving regulatory environment, regulations and standards, both domestic and international, along with developments relating to topics of interest or organization competitors. Communicate relevant changes to management and, when requested, to the broader organization

• Bachelor’s degree in a science or technical field, with at least seven (7) years of Quality or Regulatory experience in a biologic, pharmaceutical, or FDA regulated facility; or an appropriate combination of education and work experience.
• Regulatory experience in the field of tissue banking, pharmaceuticals, clinical trials, medical devices, and/or biologics is required.
• A graduate degree in pharmaceutical sciences (e.g., international biomedical regulatory affairs) or a Regulatory Affairs Certification (RAC) is preferred.   

• Knowledge and understanding of Quality and Regulatory requirements, including FDA (21 CFR Parts 1271, 820, 210, 211, 312, 812, 801, 803, etc.), The American Association of Tissue Banks’ Standards for Tissue Banking , cGTP, cGMP, HCT/P Final Guidance on Minimal Manipulation and Homologous Use, regulatory submissions, regulated product marketing and labeling, clinical trials, and other applicable state, federal, or international regulations. 
• Must be detail oriented, well-organized, capable of working independently, and able to communicate clearly across cross-functional teams.
• Must have strong technical writing and interpersonal skills. 

StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.