Principal, Regulatory Affairs Specialist
1555 Adams Drive Menlo Park, CA 94025
PURPOSE OF JOB: Responsible for providing regulatory leadership for drug/device combination products from development through global market approval and commercialization. Responsible for developing regulatory strategies for US and international submissions and for the planning, coordination, and authoring of regulatory submissions.
MAJOR DUTIES AND RESPONSIBILITIES:
- Provide regulatory representation and leadership to cross-functional product development teams and commercial project teams.
- Proactively develop regulatory strategies to support clinical and non-clinical development programs, marketing applications and post-marketing activities for combination products.
- Responsible for project timelines and management of regulatory submissions including authoring and preparing pre-submissions, IDE, PMA and international submissions (e.g. Design Dossier, Shonins) in compliance with the FDA and international regulations and guidelines.
- Responsible for the maintenance of approved applications (IDE, PMA, Design Dossier, etc.) including authoring annual reports, amendments and supplements and substantial changes, etc., as needed
- Establish, track and manage regulatory project timelines, status and documents.
- Provide regulatory assessments for anticipated design, manufacturing and labeling changes.
- Represent RA functional area in the review and approval of Engineering Change Orders (ECO).
- Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials.
- Provide regulatory assistance and review in clinical operations activities, including review of essential documents, adverse event reporting, etc.
- Perform regulatory research and stay abreast of changes in the agency regulations and requirements.
- Provide regulatory support for regulatory compliance activities as required.
- Maintain well-organized, auditable regulatory files.
- Other duties as needed
EDUCATION / REQUIREMENTS:
Minimum of Bachelor’ s degree in life sciences, engineering, or equivalent required.
- A minimum of 8 years related experience in medical device regulatory affairs
- Experience with Class III medical devices and combination products preferred.
- Established knowledge of FDA regulations including PMA, IDE, 510(k), Quality Systems, cGMP’ s, labelling, advertising/promotion
- Experience with successful regulatory submissions (510(k)/IDE/PMA) and experience with regulatory support of clinical trials
- Must be detail-oriented with well-developed organizational and analytical skills
- Must be self-motivated, capable of managing multiple projects in a fast-paced startup environment
- Must have strong oral and written communication and interpersonal skills
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).