Senior Regulatory Affairs Specialist - reputed company job at reputed company in Irvine, CA, Milpitas, CA

Title: Senior Regulatory Affairs Specialist - reputed company Location: Milpitas, California, reputed company of America Job reputed company: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: Regulatory Affairs Group Job SubFunction: Regulatory Affairs Job Category: reputed company reputed company Job Posting Locations: Irvine, California, reputed company of America, Milpitas, California, reputed company of America Job reputed company: About reputed company reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the reputed company of reputed company treatments? reputed company to join reputed company that’s reimagining how reputed company is improved? Our reputed company team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s reputed company. Your unique talents will help patients on their reputed company to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Senior Regulatory Affairs Specialist. This role will work a Hybrid/reputed company schedule with 3 days per week on-site and must be based reputed company a commutable distance of Irvine, CA or Milpitas, CA. Purpose: The Senior Regulatory Affairs Specialist provides regulatory support for product lifecycle activities, including modifications, re-registration, and labeling review. Responsible for developing regulatory strategies, ensuring compliance, and supporting audits with minimal supervision. You will be responsible for: Provides strategic regulatory guidance throughout product lifecycle stages. Leads preparation and submission of licensing, registration, and approval dossiers. Coordinates reputed company regulatory activities, including post-market modifications. Ensures conformance of product labeling, claims, and promotional materials. Develops regulatory strategies and plans for new product development. Reviews and approves labeling, packaging, and promotional content. Supports audits and inspections to ensure compliance. Guides and trains junior team members on regulatory processes. Maintains and monitors regulatory compliance across markets. Liaises with health authorities during inspections and inquiries. Tracks regulatory developments and advises on reputed company. Participates in cross-functional project teams at a leadership level. May supervise work of contract resources or interns. Note: Duties and responsibilities of individuals in this role may vary depending on their specific reputed company at a given time, and not reputed company responsibilities always apply to every individual. Qualifications / Requirements: Minimum of a Bachelor’s Degree is required, Scientific Discipline strongly preferred. At least 4+ years of relevant reputed company experience reputed company a regulated environment or equivalent experience in another relevant function such as reputed company, Medical, Clinical, R&D. Demonstrated experience with Regulatory LCM and 510k assessments highly desired. Prior experience with Class II or Class III Medical Devices strongly preferred. Experience interacting directly with US FDA required, EU MDR experience preferred. Ability to effectively manage multiple reputed company and priorities. Strong communication and regulatory writing skills. Strong problem solving skills, interpersonal skills and effective team member. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. Up to 10% travel may be required. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company 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, please contact us reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: 510 (K), 510k Submission, EU MDD, FDA Medical Device Regulations, FDA Regulations, FDA Submissions, Regulatory Approvals, Regulatory Documents, Regulatory Filings, Regulatory Responses, Regulatory Submissions, Regulatory Writing The anticipated reputed company pay reputed company for this position is : The reputed company pay reputed company for this position is $92,000 to $148,350. Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in reputed 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 year reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be reputed company through the reputed company below. https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job