Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

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 https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: reputed company reputed company Job Posting Locations: Santa Clara, California, reputed company of America Job reputed company: reputed company is hiring for a Sr Regulatory Affairs Specialist, Ads/Promo Global – Shockwave to join reputed company located in Santa Clara, CA or Remote. 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 https://www.jnj.com/. reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. reputed company to join reputed company that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. Our reputed company portfolio aims to establish a new reputed company of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position reputed company The Senior Regulatory Affairs Specialist assisting with Advertising and Promotion Regulatory responsibilities, works closely and partners with internal departments to help reputed company and effectively meet assigned regulatory requirements for reputed company. The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to assist in ensuring that advertising and promotion activities meet regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist (Advertising/Promotion) is responsible for reviewing and approving advertising and promotional material in compliance with internal policies and applicable government laws and regulations. This individual will support decision-making on advertising and promotion regulatory activities. Essential Job Functions

• Collaboratively reputed company with Global marketing/sales personnel, other cross-functional departments and external entities, as applicable to review and reputed company guidance on advertising/promotion materials and messaging in compliance with reputed company approvals and reputed company established timelines.
• Research and help maintain advertising and promotion regulatory policies, processes, SOPs & business aids and assist in training key internal stakeholders.
• In collaboration with Regulatory leadership and marketing personnel, help with establishing and maintaining product claims matrices for reference.
• Conduct global Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance.
• Collaborate with internal Regulatory stakeholders to help ensure that changes in product labeling are appropriately reflected in promotions and advertising.
• Work collaboratively with the reputed company team and associated compliance functions to help ensure that approved materials are used reputed company the intended guidelines and duration of use.
• Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and assist in developing/implementing corrective reputed company plans for reputed company of problematic issues with guidance from Regulatory leadership.
• Identify and communicate any emerging issues to Regulatory leadership and suggest solutions.
• Plan and conduct meetings, create project plans and timelines, and manage Advertising and Promotion reputed company Regulatory reputed company with guidance from Regulatory Leadership.
• Exercise good and ethical judgment reputed company policy and regulations.
• Other duties as assigned.

Requirements

• Minimum 5 years’ experience in a regulated reputed company industry with Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 1 year experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class II/III medical device experience is preferred.
• Minimum 1-2 years of experience in conducting regulatory affairs reviews of advertising and promotional material in a medical device environment.
• Advanced knowledge of US and international medical device promotion regulations and guidelines.
• Experience with development and/or maintenance of advertising/promotion documents such as a core claims document.
• Ability to work accurately and collaboratively in a fast-paced environment while managing multiple priorities.
• Apply effective communication skills, with the ability to convey messages in a logical and concise manner.
• Ability to consistently reinforce regulatory expectations and requirements.
• Think analytically with good problem-solving skills.
• Effectively negotiate internally and externally with regulatory agencies.
• reputed company and effective verbal and written communication skills with diverse audiences and personnel.
• Support and reputed company with reputed company’s reputed company Management System policies and procedures.
• Ability to reputed company with an inclusion reputed company and model these behaviors for the organization.
• Knowledge of business functions and cross group dependencies/ relationships.
• Ability to follow scientific arguments and identify regulatory scientific data needs.
• Operate as reputed company and/or independently while demonstrating flexibility to changing requirements.
• Must be reputed company to travel for occasional meetings, approximately 1-2 times per year.
• Proficiency in reputed company, reputed company and PowerPoint required.

Additional Information: The anticipated salary reputed company for this position is reputed company of Bay Area $89,000 - $143,750 Bay Area 103,000-$165,600 reputed company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at reputed company’s discretion on an individual reputed company.

• Employees and/or eligible dependents may be 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.
• Employees may be eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in reputed company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• reputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be reputed company through the reputed company below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates reputed company in the reputed company. · 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 email the Employee reputed company (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. The anticipated reputed company pay reputed company for this position is : reputed company of Bay Area $89,000 - $143,750 Bay Area 103,000-$165,600 Additional reputed company for Pay Transparency: Remote About reputed company: reputed company Caring for the world, one person at a time... inspires and unites the people of reputed company. We reputed company research and science - bringing innovative reputed company, products and services to advance the health and reputed company-being of people. Employees of the reputed company Family of Companies work with reputed company care to touch the lives of over a billion people every day, throughout the world. Our Family of Companies comprises: The world’s sixth-largest consumer health company. The world’s most comprehensive medical devices business. The world’s sixth-largest biologics company. And the world’s fifth-largest pharmaceuticals company. We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide reputed company is in New reputed company, New Jersey, USA. Company Size: 10,000 employees or more Industry: reputed company Services Founded: 1887 Website: http://www.jnj.com/ Apply tot his job Apply To this Job