Senior Regulatory Affairs Specialist

Job description

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.com As 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 Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland Job Description: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes We are searching for the best talent for Senior Regulatory Affairs Specialist in West Chester, PA , Raynham, MA. JOB SUMMARY Coordinates, compiles, and submits medical devices applications and investigational medical device applications to the regulatory bodies. DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: ·     Leverages scientific and technical understanding of regulated products within scope of responsibility (mainly NPD/NPI) to provide regulatory input to product lifecycle management and evaluate regulatory impact on products. ·     Compile, prepare, review, and submit regulatory submission to regulatory authorities. ·     Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices. ·     Interface with Product Development to obtain necessary information for regulatory submissions. ·     Review / approve Change Requests / Notices to determine the level of change and consequent submission requirements. ·     Review/approve product labeling: device labels, brochures, technique guides, bulletins, updates, etc. ·     Prepare registration documents, medical device listings, and annual establishment registrations. ·     Respond to requests for information on import detentions. ·     Maintain regulatory database – ongoing update of database with regulatory information. ·     Assist in the development and implementation of SOPs and systems to track and manage product-associated events. ·     Develop regulatory strategies and update strategies based upon regulatory changes. ·     Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations. ·     Provide regulatory input to product lifecycle planning. ·     Understand, investigate, and evaluate regulatory history / background of class, disease / therapeutic/diagnostic context in order to assess regulatory implications for approval. ·     Determine and communicate submission and approval requirements. ·     Problem-solve with and advise internal stakeholders on regulatory issues. ·     Identify standards for the organization’s products. ·     Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times. ·     Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. ·     Consults with others to understand the benefits, risks, and J&J Credo-based impact associated with decision alternatives before making decisions. ·       Responsible for communicating business related issues or opportunities to next management level. ·       For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable ·       Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures ·     Performs other duties assigned as needed EXPERIENCE AND EDUCATION ·       University / bachelor’s degree or equivalent. ·       Generally, requires 4-6 years’ work experience. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS ·       Excellent written and oral communication skills. ·       Excellent organizational skills preferred. ·       Ability to handle multiple tasks and be detail oriented. ·       Ability to apply risk-benefit analysis techniques. ·       RAC certification for Medical Devices preferred. 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 and 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, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking The anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: Subject to the terms of their respective polic