Senior Manager Regulatory Affairs
Company: Johnson & Johnson
Location: Jacksonville, Florida
Posted: July 06, 2016
Reference ID: 4480160518-en-us
Johnson & Johnson Vision Care, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Regulatory Affairs. The position will be based in Jacksonville, FL.
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
The Senior Manager, Regulatory Affairs will:
• Create and execute the strategies for obtaining new product registrations and supporting the lifecycle management of product portfolio.
• Prepare and provide oversight for submission dossier creation with respect to new products, renewals, product changes, advertising, and other licensing.
• Interpret country regulations and provide regulatory insight plus guidance to support organizational objectives, to reduce risk and to drive regulatory compliance.
• Work with Global RA to develop and implement streamlined consistent processes for both new products and life cycle management.
• Provides regulatory leadership to develop and sustain productive relationships with in-country business partners.
• Monitor the external regulatory environmental changes and engage in shaping activities through industry association.
• Maintain a positive relationship with health authorities through frequent and transparent dialogue. Represent JJVC, in partnership with Jacksonville leadership, in health authority negotiations.
• Identify and communicate regulatory requirements necessary to perform clinical studies in the assigned markets.
• Lead RA team and strengthen talent development for RA staff.
• A minimum of a Bachelor’s Degree in a scientific/technical/engineering related discipline or equivalent degree is required.
• A minimum of 8 years of Medical Device industry experience or related industry experience is required.
• Highly skilled in establishing partnerships with internal and external partners and the ability to work collaboratively in a matrix environment is required.
• Masterful communication, organizational, negotiation and interpersonal skills are required.
• Expert knowledge and hands on experience obtaining regulatory approvals for medical devices is required.
• Strategic Thinking with demonstrated ability to set effective business, technical and/or regulatory direction is required.
• Proven record of effectively negotiating and influencing upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met is required.
• Must be able to communicate clearly and effectively over the phone and in written in English.
• Experience in the field of optometry and contact lenses is a plus.
• This position is located in Jacksonville, FL and may require up to 15% domestic and international travel.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Johnson & Johnson Vision Care, Inc. (6094)