Regulatory Affairs Specialist (Seattle, WA)

Philips Medical Systems A leader in Healthcare, Philips Medical Systems is one of the world?s top three medical device companies. Our mission is to improve the quality of people?s lives.

Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It?s just one of the many ways we deliver ?advanced? technology that is ?designed around you? and ?easy to experience?.Requlatory

Job Description

Monitor sources of regulatory information for new or revised laws, regulations, directives, standards and guidance and create/update operating procedures. Train company employees in relevant regulatory or regulatory compliance matters. Responsible for US regulatory clearance/approvals processes (ie 510(k), IDE). Interface with FDA reviewers regarding submissions. Approve change control sign off process, including writing of regulatory justifications to support submission filing decisions regarding product changes. Responsible for the CE Mark and European Council Directive 93/42/EEC (MDD) programs including coordination, preparation, submission, and maintenance of international regulatory design dossier/design documents. Coordinate other required European regulatory documents and change notices. Schedule and interface with European regulators (TUV) during annual Surveillance Assessments. Coordination, preparation and submission of international registration documents and data to obtain regulatory approvals to meet desired market launch goals. Research international regulatory requirements, as required. Facilitate and assure compliance of the Heartstream quality system with the US Quality System Regulation (21CFR?820) and EN ISO 13485 and EN 46001 quality systems standards. Assist with and facilitate FDA compliance inspections. Interface with safety agency auditors (e.g., CSA) during product development and for surveillance audits of Heartstream product lines. Assist in preparation of responses for regulatory compliance matters (e.g., 483 responses). Participate in supplier audits. Review complaints in accordance with procedures and file Medical Device Reports (MDRs) and/or comparable international reports, as required. Review protocols for field or clinical trials for regulatory requirements. Review marketing materials, labeling and device instructions for compliance to United States and international regulatory labeling requirements. Coordinate and report field corrective actions as required in accordance with procedures.

Requirements

An enthusiastic, ethical individual with excellent verbal and written communication skills. This individual must be able to function as a hands-on team member and represent the company externally, as needed, to medical professionals, regulators and customers. Bachelors Degree or higher, 5+ years experience in Regulatory affairs, compliance or quality assurance experience.
Philips is an equal opportunity employer.
Job ID 35461