Regulatory Affairs Specialist II - JJMT Neurovascular

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Remote (US)Job Description:Johnson & Johnson MedTech, Neurovascular, is recruiting a Regulatory Affairs Specialist II, to join our team. This position is remote anywhere within the continental United States.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.Job Summary:The Regulatory Affairs Specialist II position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world!The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets. This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as Technical Documents, amendments/supplements, annual reports, general correspondence, promotional materials, and other EU or US regulatory submissions. The individual will work closely with other Global Regulatory Affairs partners and with functional partners in Research and Development (R&D), Medical Affairs, Quality, Supply Chain, Marketing, and other functions.Job Responsibilities:Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines:Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters.This includes but is not limited to 510(k), IDE, PMA, HDE, PMA/HDE Annual Reports, Technical Documentation Assessments, Design Examinations, Change Notifications (EU/UK), and other correspondence for new products and changes to existing products.Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.Reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.Completes assigned duties in compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.Collaborates with othersAttends regular meetings with project teams for product development and product changes, communicating applicable regulatory requirements and activities needed to gain and maintain regulatory approval in various markets.Collaborates with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agenciesCommunicates relevant technical and regulatory information to global partners to obtain local regulatory impact, and to complete required regulatory submissions.Provides Regulatory Affairs support for internal and external audits to comply with ISO 13485 and related standards.Qualifications:Experience and EducationRequired: BS with 2+ years of experience, or PhD, MS degreeREQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiencesSome knowledge of US and European regulatory processesExperienced in working as a member of a teamAbility to communicate in a constructive manner to encourage new, diverse ideas so decisions can be made in alignment with business objectives and the J&J CredoCapability to work in an environment of innovative thinking, informed risk taking, intellectual curiosity, and continual learning of regulatory developmentsLanguage requirement: Proficiency in speaking, reading, and writing in EnglishPreferred:Training in US and/or EU medical device regulationsPractical experience in a medical device regulatory environmentPractical experience working within a medical device quality systemPractical experience preparing submissions for Class II and III medical devices in the US and EURESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONSWorks with other departments such as Research and Development (R&D), medical affairs, clinical, Marketing, Supply chain and other functions to achieve business objectives.Physical working conditions / requirementsThis position does not involve conditions that may require special or unique physical abilitiesLocation & travel requirementsExpected domestic and international travel: 5%–10%Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Coaching, Communication, Competitive Landscape Analysis, Compliance Management, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Product Packaging Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Researching, Safety-Oriented, Sustainability, Sustainable PackagingThe anticipated base pay range for this position is :$76,000.00 - $121,900.00Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsOriginally posted on Himalayas