Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Regulatory Affairs, located in Somerville, NJ.
Ethicon, Inc.- Develops and markets products within three divisions: Ethicon Products Worldwide for wound closure and tissue repair; Johnson & Johnson Wound Management with biosurgical technologies to manage intra-operative bleeding and postoperative leaking, as well as advanced wound care products; and Ethicon Women's Health & Urology with minimally invasive gynecological and urological solutions in stress urinary incontinence, pelvic floor repair and uterine disorders.
The Manager, Regulatory Affairs will provide tactical and strategic regulatory management and leadership to Regulatory Affairs staff. The Manager will liaise closely with regulatory consultants and business operations staff to ensure projects are adequately staffed and managed, proceed on time, and within the designated budget. Will review scientific/technical documentation, prepare and manage regulatory submissions, liaise with internal staff, business partners, and regulatory authorities to identify and manage initiatives to improve department capabilities. The Manager, Regulatory Affairs will conduct critical reviews of key technical documents aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review.
The Manager, Regulatory Affairs will be responsible to acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and disciplines areas relevant to assigned projects, and advise clients and internal staff accordingly. Responsible to build strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Will monitor compliance with company policies and procedures. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives. Works closely with Associate(s) in preparing regulatory submissions. Assesses proposed regulations and communicates new requirements to the organization. Establishes business objectives and assists in the preparation of personal development plans for direct reports.
Qualifications
A minimum of Bachelor's degree in a technical, scientific, or medical/health discipline is required. An advanced degree is an asset. A minimum of 8+ years experience in a regulated healthcare industry is required. Direct experience in Regulatory Affairs is required. Experience with or exposure to 510(k) submissions is required. US regulations knowledge is required, with EU and International/OUS experience an asset. PMA experience is an asset. Copy review experience is an asset. RAC is an asset. Excellent verbal and written communication skills will be needed. The ability to influence and negotiate with business partners and regulatory agencies will be required. This position will be located in Somerville, NJ.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
