Regulatory Affairs Project Manager

Advanced Medical Optics, Inc., as an independent company, will be a highly viable enterprise as the world's second largest ophthalmic surgical company, in the markets in which it competes, and the world's second largest contact lens care company. AMO is currently the world's fastest growing company in the sale of foldable intraocular lenses for cataracts. AMO possesses well-known products and brands, superb technology, and experienced entrepreneurial management.

The Regulatory Affairs Project Manager, is responsible for defining and implementing global regulatory strategies and submissions in support of new and existing products. The position will represent Global Regulatory Affairs on cross-functional project teams, and ensure alignment with business goals for projects. The position is responsible for US submissions (510(k)s/PMAs/IDEs) and regulatory submission compliance for assigned products. Responsibilities also include leading interactions with international regulatory colleagues to ensure appropriate communication and alignment to support global requirements and device submissions.



ESSENTIAL DUTIES AND RESPONSIBILITIES Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations. Represent or lead the RA function on assigned cross-functional project teams Monitor applicable regulatory requirements; assure compliance with AMO and external standards. Manage and resolve submission issues. Advise on issues of product/process quality and risk assessment. Establish appropriate communication within RA and other functions primarily at project level. Develop and document sound regulatory decisions and justifications. Ensure project teams, business objectives, and deliverables are aligned with regulatory strategy. May review promotional material or SOP's for compliance with local and global regulations.
REQUIREMENTS
Sound basis of regulatory knowledge. Specific knowledge of regulatory expectations for software driven medical devices. Proven ability to prepare device applications for the US (i.e. IDEs, 510(k)s, PMAs). Ability to manage complex projects and timelines within a project team environment Strong oral and written communication and presentation skills Demonstrated interpersonal skills including strong negotiation skills Ability to independently identify compliance risks and escalate when necessary

EDUCATION AND EXPERIENCE



Bachelor's degree in related scientific discipline with a minimum of 7 years regulatory experience in RA or related field. Higher degree/PhD will be an advantage.



Advanced Medical Optics offers a competitive salary and generous benefits package. This includes healthcare coverage, 401 (k), profit sharing, employee stock purchase plan and much more. At AMO, people make the difference and have the opportunity to be a part of a global company that it a major force in the medical device industry.

AA/EOE M/F/D/V