Offer summary

Qualifications:

Bachelor's or master's degree in biomedical engineering, regulatory affairs, public health, or related fields preferred., 3-5 years of experience in health hazard evaluations (HHEs)., In-depth knowledge of diagnostics, particularly in oncology or pathology, is essential., Strong analytical, writing, and communication skills are required. .

Key responsabilities:

Conduct comprehensive health hazard evaluations (HHEs) for medical devices and IVDs.

Collaborate with cross-functional teams to assess patient risk and ensure regulatory compliance.

Review complaint information and assist with investigations and adverse event documentation.

Monitor post-market safety signals and contribute to product safety improvements.

Job description

Job Description

We are seeking a detailed-oriented and experienced Product Incident Risk Management expert to lead health hazard evaluations and contribute to risk assessments for medical devices an invitro diagnostics (IVDs). The ideal candidate will play a key role in supporting product safety, regulatory compliance and post market surveillance activities.

In addition to these core responsibilities, the Post Market Risk Management Expert will conduct thorough reviews of complaints, and other relevant technical literature. The Expert will also be involved in helping our clinical sponsor-customers align their Safety Reporting Plans, and Site-Specific Safety Communication Plans and agreements with regulatory reporting requirements for clinical trials. Other relevant duties will be assigned as needed.

Responsibilities:

Conducts and documents comprehensive health hazard evaluations (HHEs) for identified product issues, meticulously considering the clinical application and usage of the product in real-world healthcare settings.
Ability to write, review and communicate clinical and diagnostic information

Reviews complaint information for compliance to procedures and assists with complaint investigations and adverse event write ups.

Collaborate with cross-functional teams including Regulatory, Quality, Engineering, and Clinical teams to evaluate patient risk.
Analyze and interpret product performance data and clinical literature to determine their influence on clinical outcomes, and compliance with regulatory standards

Demonstrates a thorough understanding and ensures compliance to FDA, EU MDR, IVDR Health Canada, etc. regulations and guidelines to author, and review HHEs and Risk Assessments
Monitor and interpret post market safety signals and contribute to continuous improvement in product safety
Collaborates with customers sponsoring clinical trials to review and assess the adequacy of the Safety Reporting plan, supporting both new and ongoing clinical studies for reporting SAEs as adverse events in accordance with IDE and global regulations

Qualifications

Bachelors or master’s in biomedical engineering, regulatory affairs, public health or microbiology, biochemistry specifically for IVDs, preferred.
3-5 years' experience facilitating health hazard evaluations (HHEs).
Possesses in-depth skills acquired through advanced training, study and experience in diagnostics or companion diagnostics in oncology, pathology or NGS liquid biopsy.
Allied health professional (AHP) or related disciplines, preferred
Experience reviewing health hazard evaluations.
Knowledge of human factors and use error analysis is plus.
Excellent analytical, writing, and cross functional collaboration skills.
Risk Management ISO 14971 and international safety standards.
Knows how to navigate FDAs MAUDE, FDA Recalls database, Canada’s MDALL, TGA’s TGA DEN and other safety databases.
Some experience with Pathology, Cancer Screening Test, Diagnosis and Treatment regimens is preferred.
Ability to write and review clinical and diagnostic information and have strong presentation and communication skills.

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least April 28, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $121,600.00 - $228,000.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.