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Regulatory Affairs Manager - 2306150886WDescriptionDescription – ExternalAcclarent, part of the Johnson & Johnson family of companies, is currently recruiting for a Manager of Regulatory Affairs that can be based anywhere in the United States.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. Learn more about Acclarent at http://acclarent.com/ and follow us on LinkedIn (https://www.linkedin.com/company/acclarent/) .SummaryThe Manager, Regulatory Affairs, develops global regulatory strategies for Acclarent’s new and revised medical devices and communicates directly with regulatory agencies on behalf of Acclarent for responsible products and projects.Key Duties/ResponsibilitiesUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
Instill and drive a regulatory culture. Establish and support policies and standards for new products.
Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by Acclarent and/or J&J affiliates.
Develop regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
Develop technical documents for products to be distributed in the EU (CE Mark Approval).
Reviews and approves engineering change notifications, advertising and promotional material and labels.
Maintain proficiency on regulatory requirements; develop and maintain rapport with
FDA reviewers, project team members.
Communicates regulatory strategies to project team members and provides regulatory guidance, as necessary.
Communicates directly with regulatory agencies, including the notified body and FDA.
Shares responsibility for communicating with senior management, providing highlights and updates on status of projects, as necessary
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 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.
Other responsibilities as required or assigned by manager
QualificationsQualificationsRequired Education & Skills/Experience:
Bachelor’s degree or equivalent.
At least 8 years regulatory affairs experience including 6 years working with medical devices, or at least 6 years regulatory affairs experience with an advanced degree
Excellent written and oral communication and presentation skills.
Must be detail-oriented, work well with a team, exhibit initiative and be passionate
Motivated and self-starter who can work independently once projects are assigned.
Demonstrated knowledge of FDA regulations for medical devices.
Experience writing FDA submissions and communicating with CDRH.
Strong interpersonal, organizational, and problem-solving skills.
Ability to manage multiple priorities effectively.
Strong negotiation skills as it relates to regulatory bodies worldwide.
Proficiency in Microsoft Word, Excel and PowerPoint.
Preferred Education & Skills/Experience:
Bachelor’s degree or master’s degree in a scientific or technical field.
Global experience
Supervisory experience
A basic understanding of sinus disease and treatments.
Regulatory experience working with all three classes of medical devices (1, 2 and 3).
510(k) experience
Other:
This position may require up to 10% domestic and international travel.
Remote-based in the United States
The base pay range for this position is $111,000 - $165,000.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, [long-term incentive – include LTI only if applicable] disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below:https://www.careers.jnj.com/employee-benefitsJohnson & 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.Primary Location NA-United StatesOrganization Medical Device Business Services, Inc (6029)Relocation Eligible: NoJob Function Regulatory AffairsReq ID: 2306150886W
