Regulatory Technical Spec 3

Purpose: Company: Siemens Medical Solutions USA, Inc.

Division: SMS - Oncology Care Systems Group

Req ID: 39269

Position Title: Regulatory Technical Spec 3

Company Description:
We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry.

Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.

Job Description:
May include one or more of the following, other duties may be assigned:
Monitor documentation in the interest of product safety and applicable regulation conformance. Review ECO’s for changes that might have safety or regulatory impact.
Offer regulatory support to other engineering areas, manufacturing departments, internal customers, and the service organization.
Consult on new designs for worldwide compliance and regulatory issues relating to electronic boards, systems, and modules (may include determination of critical components).
Participate in hazard analysis meetings and design reviews as assigned.
Prepare regulatory submission document packages (ie. 510(k), foreign license applications, MDRs/Vigilance, Correction and Removals, etc., to achieve governmental approvals and/or reporting compliance.
Provide regulatory direction and oversight for Risk Management activities, including risk assessment of Product Development efforts, and corrective action consulting.
Participate in complaint review and in MDR/Vigilance reporting determinations
Participate in Field actions to monitor proper tracking and determination as assigned.
Provide regultory review of promotional literature and labelling
Author and/or provide regulatory review of various internal procedures and documents as assigned.
Job Family Responsibilities:
Performs the writing and filing appropriate FDA premarket submission to ensure devices are commercially available in the U.S. Completes the review of promotional material and device labeling for regulatory compliance. Completes regulatory projects, project schedules, and product introduction process. Completes decision making on regulatory submission issues using historical knowledge, legal counsel and FDAs current regulations on medical device industry. Performs training of quality counterpart in Germany on FDA requirements.

Key Responsibilities:
Performs full range of standard work for the professional field. Refers complex, unusual problems to others. Identifies and resolves more complex problems and applies problem-solving skills in order to deal with most situations.

Education:
Typically BS/BA in related discipline or advanced degree. Certification may be required in some areas.

Knowledge and Experience:
Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organizations business practices and issues. Typically 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.

Direction of Others:
Provide general guidance or train support and/or professional staff.

Key Working Relationships:
Primarily intra-organizational contacts and external contacts.
Job Family Responsibilities:
Performs the writing and filing appropriate FDA premarket submission to ensure devices are commercially available in the U.S. Completes the review of promotional material and device labeling for regulatory compliance. Completes regulatory projects, project schedules, and product introduction process. Completes decision making on regulatory submission issues using historical knowledge, legal counsel and FDAs current regulations on medical device industry. Performs training of quality counterpart in Germany on FDA requirements.

Key Responsibilities:
Performs full range of standard work for the professional field. Refers complex, unusual problems to others. Identifies and resolves more complex problems and applies problem-solving skills in order to deal with most situations.

Education:
Typically BS/BA in related discipline or advanced degree. Certification may be required in some areas.

Knowledge and Experience:
Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organizations business practices and issues. Typically 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.

Direction of Others:
Provide general guidance or train support and/or professional staff.

Key Working Relationships:
Primarily intra-organizational contacts and external contacts.

Compensation:
There is assistance available for relocation.
Job Requirements:
Travel Percentage: 25%


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