Siemens Careers

Reg Clinical Affairs Spec 3

Flanders, New Jersey
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 232782
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 20%

Division Description:

Siemens

Job Description:


Specific Requirements
Position Overview
- Siemens’ Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a leader in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens Healthcare offers its customers products and solutions for the entire lifecycle of patient care – from prevention and early detection, to diagnosis, treatment, and aftercare.
- For this job, the successful candidate will develop and execute regulatory strategy for design changes for commercialized in vitro diagnostic products and for new product development.
- The candidate will represent Regulatory Affairs on Product Development Teams (PDP) and/or Design Change Teams 

Responsibilities
- Executes regulatory strategy for assigned projects and interacts with regulatory authorities.
- Provides RA assessments for Instruments, Automation and Informatics products design change and process change Review Board (CRB). Interacts with Regional units RA colleagues to communicate design changes to determine regulatory impacts in their country
- Provides back up support to perform releases and restrictions of product for distribution in SAP P41 for commercial, registered products
- Maintains awareness of global regulatory legislation and assesses impact of changes to the business.
- Consults and provides training related to regulations and regulatory requirements.
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.

Required Knowledge/Skills, Education, and Experience
 -              Minimum 2 – 4 years medical device/in vitro diagnostics regulatory or equivalent experience
  • Knowledge of IVD automated analyzers, Automation and Informatics products preferred.
    - Knowledge and experience with development of in-vitro medical devices a plus.
    - Knowledge of software and instrument development a plus
    - Strong leadership, interpersonal, communication and organizational skills required.
    - Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
    - Must be able to set priorities as well as adapt to changing priorities
General Requirements
Job Family Responsibilities:
Provides regulatory support for in vitro diagnostic commercialized Analyzers.  Assesses regulatory impact of design and manufacturing process changes and, as needed, prepares/submits 510(k)s, PMA 30 Day notices and supplements, updates to IVDD documentation and prepares 510(k) notes to file.  Communicates changes to Regional RA teams as needed. Provides input for PMA annual reports and information for Canadian license renewals. Maintains awareness of global regulatory legislation and assesses impact of changes to the business. Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.  
 
 


Education:

BS/BA in related discipline or equivalent combination of education and experience.
 
Direction of Others:

Develops team members through mentoring and coaching in complex subjects.

Key Working Relationships:

Primarily intra-organizational contacts and external contacts.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

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, ancestry, national origin, sex, sexual orientation, gender identity, age, marital status, family responsibilities, pregnancy, genetic information, protected veteran or military status, other categories protected by federal, state, or local law, and regardless of whether the qualified applicants are individuals with disabilities.

EEO is the Law:
Applicants and employees are protected under Federal law from discrimination.


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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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