J&J Family of Companies Regulatory Affairs Manager – Acclarent in Warsaw, Indiana
Johnson & Johnson's Family of Companies is recruiting for an Regulatory Affairs Manager to be located in Irvine, CA to support our Acclarent business.
Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that’s been used to treat more than one million patients.
You the Manager, Regulatory Affairs, will be responsible for the preparation of regulatory submissions required to market new or modified medical devices in both domestic and international markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements and the objectives of the business.
You, the Regulatory Affairs Manager will:
• Prepare FDA and international submissions for new products and product changes, as required, to ensure timely approval for market release. Communicate directly with international affiliates and regulatory agency personnel.
• Execute regulatory strategies/plans. Provide ongoing support to product development teams for regulatory issues/questions.
• Provide support to new and currently marketed products as necessary. This includes reviewing labeling, promotional material, and other post-market activities.
• Provide support to Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers.
• Ensure regulatory affairs files are maintained to support compliance with regulatory requirements.
• Support internal and external audits by regulatory agencies as required.
• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Responsible for ensuring that direct reports follow all company guidelines related to Health, Safety and Environmental practices
• Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development.
• Assist in the identification and management of departmental project and personnel issues.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure
• Perform Copy Review for internal and external facing documentation to ensure compliance with applicable Federal, State, local and Company regulations, policies, and procedures
• Other responsibilities as required or assigned by manager.
• A bachelor’s degree and a minimum of 8 years of related experience is required.
• An advanced degree is preferred
• Knowledgeable in FDA, EU health regulations and other international regulations pertaining to the design, manufacture and commercialization of medical devices is required.
• Previous experience development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers is preferred
• Previous experience reviewing labeling, promotional material is preferred
• Previous experience supporting internal and external audits by regulatory agencies is preferred
• Computer skills, including proficiency with Microsoft Word, Excel, PowerPoint and Project are required.
• Direct experience in medical device regulatory affairs is required.
• Direct experience as People manager is preferred.
• This position will be located in Irvine, CA, Somerville NJ, Warsaw, IN, Raynham, MA, West Chester PA, Cincinnati OH and may require up to 10% domestic and/or international travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-Indiana-Warsaw, United States-Pennsylvania-West Chester, United States-Massachusetts-Raynham, United States-New Jersey-Somerville, United States-Ohio-Cincinnati
Mentor Worldwide LLC (6177)