Eckert & Ziegler Isotope Products, Inc.

Regulatory Affairs Specialist

SANTA CLARITA, CAPosted 23 days ago

Job summary

  • Job post source

    This job is directly from Eckert & Ziegler Isotope Products, Inc.

  • Job overview

    The Regulatory Affairs Specialist at Eckert & Ziegler Isotope Products supports quality operations and regulatory compliance to ensure high-quality product delivery in medical isotope technology.

  • Responsibilities and impact

    The role involves managing regulatory submissions, CAPAs, customer complaints, conducting audits, maintaining compliance with multiple regulatory standards, liaising with agencies, and supporting quality system documentation and testing.

  • Compensation and benefits

    The position offers an hourly wage of $38.46 to $48.08 depending on experience, 100% employer-paid medical and dental insurance, 401(k) matching, generous PTO and holidays, long-term disability, life and AD&D insurance, flexible spending accounts, tuition reimbursement, and a profit-sharing program.

  • Experience and skills

    Candidates must have a bachelor's degree in a scientific field, 4+ years of regulatory affairs experience in medical devices or pharmaceuticals, certified lead auditor status, knowledge of FDA and international regulations, strong documentation and QA system experience, and excellent communication and project management skills.

  • Work environment and culture

    The company promotes equal opportunity employment and values diversity, with a focus on quality, compliance, and saving lives through isotope technology.

  • Company information

    Eckert & Ziegler Group is a leading global provider of isotope technology for medical, scientific, and industrial applications, specializing in nuclear medicine imaging, cancer therapy, and industrial radiometry.

  • Job location and travel

    The position is onsite in Valencia, CA, with occasional work in Burbank, CA, and requires some travel between these locations.

  • Application process

    Applicants must apply through the provided ADP Workforce Now link, with no additional application instructions specified.

  • Unique job features

    The job includes unique responsibilities such as maintaining compliance with a broad range of international regulatory standards, conducting specialized testing like capsule and Type A package testing, and serving as a lead auditor for internal and supplier audits.

Company overview

Eckert & Ziegler Isotope Products specializes in the production and distribution of radioactive components for medical, scientific, and industrial applications. They generate revenue through the sale of isotopes used in cancer treatment, nuclear medicine, and industrial radiography. Founded in 1992, the company has grown to become a global leader in isotope technology, known for its high-quality products and innovative solutions. Understanding their commitment to safety and regulatory compliance is crucial for any potential candidate.

How to land this job

  • Position your resume to emphasize your experience with regulatory submissions, quality systems (FDA, ISO 9001/13485, MDR/MDD, MDSAP), and internal auditing, as these are key responsibilities at Eckert & Ziegler Isotope Products, Inc.

  • Highlight your ability to manage regulatory compliance, CAPA systems, customer complaint evaluations, and liaison with regulatory agencies, showcasing your organizational and communication skills.

  • Apply through multiple channels including the Eckert & Ziegler corporate careers page and LinkedIn to maximize your application visibility.

  • Connect on LinkedIn with professionals in the Regulatory Affairs or Quality Operations divisions at Eckert & Ziegler, using ice breakers such as asking about their experience with FDA or ISO compliance or inquiring about current challenges in regulatory submissions.

  • Optimize your resume for ATS by incorporating keywords from the job description like 'Regulatory Affairs,' 'FDA 21 CFR 820,' 'ISO 13485,' 'CAPA,' 'internal audits,' and 'regulatory submissions' to ensure it passes initial screenings.

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