17 days old

Regulatory Clinical Affairs Specialist

Issaquah, WA
**Regulatory Clinical Affairs Specialist**

Locations:Issaquah, Washington

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Ultrasound

**Requisition Number:** 218539

**Primary Location:** United States-Washington-Issaquah

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 20%

**Division Description:**


**Job Description:**

Regulatory Clinical Affairs Job Description (Issaquah, WA):

Under the direction of Regulatory Clinical Affairs and in collaboration with Product Management & Clinical Marketing, ensure regulatory compliance and development of investigational plans/protocols, including case report forms and/or advising the company on the appropriate study design.

Coordinate/assist in conjunction with Product Management, the qualification of all investigational sites, contract research organizations and investigators and provide ongoing interface and monitoring of same.

Performs and/or trains on the implementation and conduct of clinical studies to assure data are collected in timely and cost effective manner and is consistent with regulatory standards.

Independently and consistently manage all aspects of clinical studies including assisting with contracts/budgets for the collaboration sites.

Facilitates Institutional Review Board/Ethics Committee approval of clinical projects and supports regulatory submissions. Communicates with the appropriate team members during the submission process.

Provide regulatory oversight in the screening, enrollment, and subject consent for both internal and external clinical studies

Proactively work to improve systems and procedures and act as a cross-functional liaison with legal, quality, product management and clinical teams. May develop SOPs, processes, and templates to strategically standardize clinical tasks and improve efficiency.

Participate in team meetings on behalf of the Regulatory Clinical Affairs to provide regulatory advice and risk management strategies.

Contributes to new ideas to help improve efficiency of clinical tasks and project execution

Required Skills

Must be detail oriented and have excellent interpersonal, organizational, and communication skills.

Excellent writing of technical documents

Must be a self-starting individual who requires minimal direct supervision.

Knowledge of ICH / GCP, EU MDR and FDA regulations desirable.

Strong critical/analytical thinking and problem solving skills.

Required Experience

1. BA/BS degree in biological sciences or Medical Technology

2. 5+ years experience in regulatory affairs, clinical affairs, clinical research, monitoring with experience in data analysis, statistics and word processing, or equivalent combination of education and experience.

3. Previous experience with imaging or medical device industry or clinical lab is desirable.

**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/pay-transp_formattedESQA508c.pdf .


  • Biotechnology / Science
  • Legal
  • Marketing
  • Healthcare

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Issaquah, WA

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