Senior Regulatory Affairs Specialist - Organogenesis : Job Details

About UsWe are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our mission is to advance healing and recovery beyond expectations.What You Will Achieve:In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified commercial or investigational products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for post-marketing activities and product changes to US marketed products. This position reports to the Director of Regulatory Affairs.How You Will Achieve It:Working closely with Research & Development, Process Development, Manufacturing, and Quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing regulatory documentation and technical reports, as well as formulating and executing regulatory decisions/actions.Lead and/or present during working meetings, including performing follow up activities to collaborate on regulatory submissions and activities that require input from cross functional stakeholders.Lead department strategic initiatives and training, including but not limited to assisting with onboarding/training of new hires and internal process improvements.Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies.Ensuring regulatory compliance with QSR/ISO 13485, cGCP, and cGMP requirements and stay apprised of ICH, FDA, and EU requirements.Evaluating changes to determine the filing requirements and impact on product regulatory status, AATB certifications, State licenses, and FDA registrations by authoring regulatory assessments.Review of labeling changes, and advertising and promotional material.Review of complaints to complete regulatory reporting determinations and regulatory filings for medical devices and biologic products.Review of biologic deviations to complete regulatory reporting determinations and regulatory filings for biologic products.RequirementsWhat You Need to Achieve It:A BS degree in life sciences or related scientific disciplineAdvanced degree(s) preferred and RAC5 years' relevant experience in medical device, biotech industry; with a minimum of 3 years' experience in Regulatory AffairsWorking knowledge in the submission of regulatory filings for device and/or biologic productsExperience with 510(k), PMA, IND, BLA regulatory submissions is preferredPrior experience with medical device product development and registrations is a plus.Ability to prioritize and multi-task projects independently is required.Strong organizational, interpersonal, and written/verbal communication skills are required.What can we offer you?401k -- generous employer match with immediate vesting and financial planning resourcesComprehensive Medical, Dental and Vision coverage options effective on day one of employmentFlexible Spending Account (medical expenses or dependent care expenses) or Health Savings AccountCompany paid insurances including Short Term, Long Term and Life insurances as well as voluntary optionsPaid maternity leave and parental leave for all new parentsAdoption benefitsEducation Assistance Policy - up to $5,000 per year for all employeesWellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and moreEmployee Assistance ProgramGenerous paid time off including vacation, floating holidays, sick days, and company holidaysFree parking including an electric charging station (Canton and La Jolla)Discounts at BJs Wholesale, Dell, Sullivan Tire, and SprintWe are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.#J-18808-Ljbffr