SANTA CLARITA, CAPosted 20 days ago

Job summary

• Job post source

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

• Job overview

  The Regulatory Affairs Manager at Eckert & Ziegler Isotope Products oversees regulatory compliance and quality assurance programs to ensure high-quality products in medical isotope technology.

• Responsibilities and impact

  The manager supports the Director of Quality Operations, maintains regulatory compliance, conducts audits and training, manages documentation, handles customer complaints, and leads the Regulatory Affairs program including product registrations and licensing.

• Compensation and benefits

  The position offers a salary range of $100,000 to $140,000 annually depending on experience, with 100% employer-paid medical and dental insurance, 401(k) matching, generous PTO, long-term disability, life insurance, tuition reimbursement, and profit-sharing.

• Experience and skills

  Candidates need a bachelor's degree or equivalent in a scientific field, 5 years of relevant experience in medical devices or pharmaceuticals including regulatory affairs and management, strong knowledge of regulatory standards like MDSAP, FDA, EU MDR, and auditing skills, plus proficiency in Microsoft Dynamics and other office software.

• Work environment and culture

  The company values compliance, quality, and employee development with a focus on teamwork and communication in a regulated medical isotope environment.

• Company information

  Eckert & Ziegler Isotope Products is a global leader in isotope technology for medical, scientific, and industrial applications, specializing in diagnostic nuclear medicine, cancer therapy, and industrial radiometry.

• Job location and travel

  The position is onsite in Valencia and Burbank, California, requiring travel between these locations.

• Application process

  Applicants must apply through the provided ADP recruitment link and comply with the company's equal opportunity employment policy.

• Unique job features

  The role involves managing compliance with multiple international regulatory standards and leading quality and regulatory training, audits, and documentation control in a specialized isotope products company.

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

• Tailor your resume to emphasize your expertise in Regulatory Affairs management, focusing on your experience with FDA, EU MDR, MDSAP, ISO standards, and medical device regulatory compliance.

• Highlight leadership skills, including managing teams, conducting audits, and overseeing Quality Management Systems, as these are key responsibilities for this role.

• Apply through multiple channels such as Eckert & Ziegler Isotope Products' corporate careers page and LinkedIn to maximize your visibility to recruiters.

• Connect with current Regulatory Affairs or Quality Operations personnel at Eckert & Ziegler on LinkedIn; use ice breakers like commenting on recent regulatory changes impacting medical devices or asking about their experience navigating international product registrations.

• Optimize your resume for ATS by incorporating keywords from the job description such as 'Regulatory Affairs Manager,' 'FDA submissions,' 'ISO 9001,' 'MDSAP,' 'EU MDR,' 'CAPA,' and 'Quality Management System' to ensure it passes automated screenings.

• Utilize Jennie Johnson's Power Apply feature to automate applying across multiple platforms, tailor your resume for ATS, and identify LinkedIn connections to network with, freeing you to focus on interview preparation and skill development.