Sr. 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 marketing approval and commercialization. Responsible for the coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines and standards. Responsible for providing regulatory guidance to project teams and review/approval of test protocols/reports, COs, complaints, etc.
MAJOR DUTIES AND RESPONSIBILITIES:
- Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support for products, marketing applications and post-marketing activities.
- Responsible for project timelines and management of regulatory submissions including preparing IDE, PMA and international submissions to ensure compliance with the FDA and international regulations and guidelines.
- Participate on development teams to represent functional area, providing regulatory support and guidance.
- Lead regulatory activities including planning and reviewing of chemistry, manufacturing and control and nonclinical sections of regulatory submissions.
- 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 quality assurance and regulatory compliance activities as required.
- Maintain well-organized, auditable regulatory files.
- Write and maintain applicable departmental SOPs.
Minimum of BS in life sciences, engineering, or equivalent required
- Minimum six years’ 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 in developing and submitting successful regulatory submissions with a thorough understanding of FDA regulations and ICH guidelines
- Excellent presentation, verbal and written communication skills
- Experience with original PMAs and combination products preferred.
- Must be detail-oriented with well-developed organizational and analytical skills.
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
- Must enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.
Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
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, and Working Conditions:
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.
The worker is subject to inside environmental conditions: Protection from weather conditions but not necessarily from temperature changes.