Siemens Regulatory Technical Spec 2 in Norwood, Massachusetts

Regulatory Technical Spec 2

Locations:Norwood, Massachusetts

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Point of Care

Requisition Number: 200471

Assignment Category: Full-time regular

Experience Level: Mid level

Education Required Level: Bachelor's Degree

Travel Required: 10%

Division Description:

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

Job Description:

Specific Requirements

Position Overview

• Supports Regulatory activities under the Post-Market RA Team.

  • Fulfills documentation requests to support International regulatory registrations and Commercial regulatory activities (i.e. design changes) of IVD medical devices for POC. By providing support to international registrations, this role supports business expansion into markets outside the US and EU.

• May also manage small projects.

Responsibilities

• Tracks and fulfills regulatory documentation pertaining to International registrations for new products and for product design changes.

• Completes regulatory documentation for CE Marking IVD medical devices (Technical Files, Declarations of Conformity etc.)

  • Manage product registration projects in the Regulatory Affairs Product Information Database tool and collaborate with other Regional RA colleagues for completing registration projects.

• May fulfill requests for Certificates to Foreign Governments, Free Sale Certificates. .

  • Completes RA Assessments / 510(k) Note-to-Files for design change projects.

  • Conducts review of labeling and advertising/promotional pieces.

• Assists the Pre-Market Regulatory team with the international requirements needed for regulatory plans.

• Notifies countries of product changes and collects registration information for product teams.

• Confirms registration and release of product for sale into country.

• Participate in global communication activities (teleconferences etc.)..

Required Knowledge/Skills, Education, and Experience

• Required Bachelor’s degree (preferred in life sciences)

• Required industry experience: 2-5 years

• Less than 10% travel

• Demonstrated attention to detail, able to manage and track multiple requests at once.

**LI-EMM

Equal Employment Opportunity Statement

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/PayTransparencyNotice_JRFQA508c.pdf .