Business Unit: Quality
Requisition Number: 245048
Primary Location: United States-Pennsylvania-Malvern
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Associate's Degree / College Diploma
Travel Required: 5%
This position will provide support to Regulatory Affairs Organization which is comprised of two departments: Post Market Regulatory Compliance (PMRC) and Pre-Market Regulatory Affairs. As a member of the Regulatory Affairs Organization, you join a diverse team whose members serve as liaisons between our business area/line manufacturers and government regulatory agencies within the U.S. and Canada, control the introduction of products to the market, ensure that product labeling and marketing materials adhere to clearance claims and regulations, and provide support with complaint submissions.
Assists internal and 3rd party technical service engineers with submission of complaints.
Monitors government agencies (FDA & Health Canada) recall/safety alert and/or FDA 510(k) websites and prepares periodic reports.
Performs a quality assurance review of reactive service notifications.
Plans and prepares product related submissions with Siemens internal or external organizations according to regulatory requirements.
Research, analyze, consolidate and interpret data using statistical and data analytics methods to create information for business-relevant topics.
Acquires data from primary or secondary data sources and maintain databases/data systems.
Operates and optimizes pre-defined tools, applications and databases/data management systems.
Creates reports and communicates results to various internal and/or external stakeholders.
Assigned to regulatory projects and additional tasks by Director.
Provides support to business areas/business lines when they are involved in an audit or inspection.
REQUIRED KNOWLEDGE/SKILLS, EDUCATION, and EXPERIENCE:
Associates degree or equivalent experience.
- 3-5 years of regulatory affairs experience in a medical device company.
Excellent written and oral communications skills; including writing, editing and proofing skills.
Demonstrated high level of accuracy and attention to detail.
Advanced/Expert level ability with Microsoft Office Excel.
Intermediate level ability with Microsoft Office Products (e.g. Word, PowerPoint and Outlook).
Proven ability to work in a fast-paced environment with multiple projects and competing deadlines.
Experience with database creation.
Willing to take ownership and able to work under pressure (able to meet deadlines).
Highly motivated and dynamic, with an ability to learn at an accelerated pace.
Experience with SAP and Qlik preferred, but not required.