Regulatory Affairs Manager

Regulatory Affairs Manager – Valencia & Burbank, CA

Company Benefits

- 100% employer paid medical and dental

- 401(k) matching contribution

- Generous PTO and paid holidays

- Long-term disability

- Life and AD&D

- Health Care and Dependent Care Flex Spending

- Tuition reimbursement

- Profit-sharing program

Pay: $100,000 - $140,000

annually (DOE)

Position is Onsite

Company Overview

Contributing to Saving Lives

The Eckert & Ziegler Group

 is one of the world's largest providers of isotope technology for medical, scientific, and industrial use. The core businesses of the Group are Diagnostic Nuclear Medicine Imaging, Cancer Therapy, and Industrial Radiometry.

Business Segment Overview

Eckert & Ziegler Isotope Products

provides sealed and unsealed radiation sources and materials for Medical Imaging sources; Industrial sources for measurement and analysis; Oil Well Logging sources and related products; Reference, Calibration and Environmental Monitoring sources and solutions; Bulk radioisotopes for pharmaceutical, therapeutic and industrial product manufacturing; Services for collection, recycling and disposal of sources and low-activity waste; Sources for industrial Non-Destructive Testing; High-Activity radiation sources for radiation processing and sterilization; Medical and Industrial irradiators for blood irradiation, sterilization or calibration.

The Job

Eckert & Ziegler Isotope Products seeks a

Regulatory Affairs Manager

to join our team. The Regulatory Affairs Manager supports the Director of Quality Operations in maintaining an effective Regulatory Affairs (RA) & Quality Assurance (QA) program, and Quality Management System which consistently delivers high quality products. This person audits all activities to verify that appropriate current procedures are followed and keeps the Director of Quality Operations and other designates fully informed, through verbal and written reports and memoranda, on the status of RA, QC, and QA activities, problems, and customer complaints. This person and their team assist in maintaining the company’s regulatory compliance program.

ESSENTIAL DUTIES:

- Operates under the guidance of the Director of Quality Operations as necessary, to assure compliance with the company Quality System and Regulatory Affairs program.

- Keeps the Director of Quality Operations informed of activities through reports, memos, and meetings; serves as back-up to the Director of Quality Operations and Regulatory Affairs Officer.

- Acts as the Calibration Laboratory Management Representative.

- Maintains an ISO 9001, MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820)), FDB, CA-RHB (Radiological Health Branch-product registrations, compliance, & licensing), Nuclear Regulatory Commission (NRC), Bureau of Industry & Security (BIS), DOT 49 CFR / IAEA, DAkkS / ISO 17025 , and Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745) CE Mark compliant Quality Management System.

- Maintains CA-RHB (Radiological Health Branch) product registrations and licensing.

- Conducts annual cGMP and new employee training, as required.

- Maintains additional regulatory systems and compliance as required.

- Conducts revision process of old procedures as necessary to maintain Quality Control and Quality Assurance of the products.

- Responsible for holding group and individual seminars on the Quality & Regulatory System.

- Performs and leads formal audits and issue Corrective Action & Preventive Action (CAPAs) as necessary to the appropriate department.

- Close CAPARs and conduct evaluations of the corrective action system.

- Writes and maintains internal audit reports and maintains a historical file of such audits.

- Conducts training for internal auditors; schedules and performs the audit of suppliers.

- Maintain files on the current suppliers QA/QC Manuals and the audit results, approved supplier program, and historical audit files.

- Responsible for Regulatory Affairs program.

- Conducts customer license reviews, regulatory reviews for SS&DRs, CMDR licenses, RMLs, MDD/MDR, export control, and others as applicable.

- Contacts regulatory agencies and customers as required.

- Applies for export licenses from BIS and NRC as required.

- Maintains sealed source and device registries, including submissions, amendments, and transfers. (NRC, State Regulatory, and CA-RHB)

- Maintains Special Form Radioactive Materials compliance (DOT).

- Creates and approves capsule / package test report documentation and certificates (DOT).

- Maintains Health Canada establishment registration, device license submittals, and renewals.

- Maintains technical files for MDD / MDR (CE Mark) compliance.

- Research and prepare documents required for registering products for sale internationally.

- Assists the Document Management Program.

- Has final approval on all controlled procedures, procedure revisions, Engineering Drawings, and Engineering Change Orders.

- Supports all activities related to documentation control.

- Responsible for the Customer Complaints and Returns program.

- Evaluates customer complaints, with input from Sales as needed, and assist in the maintenance of the returned sources program.

- Has final approval of Complaints and Returns reports.

- Assists in scheduling, participating, follow-up, or leading external audits by customers and regulatory agencies as required.

- Assists in the company wide training program by formulating and conducting Quality and Regulatory training.

- Interviews with employment candidates and makes hiring suggestions to upper management.

- Plans, assigns, and directs work.

- Sets / oversees department goals and objectives and works towards reaching those goals.

- Trains and motivates employees.

- Conducts employee performance appraisals.

- Rewards and disciplines employees, addressing complaints and resolving problems.

- Performs other duties as required by management.

Requirements:

- Minimum education (or substitute experience) required:

Bachelor’s degree or equivalent in a scientific related field.

- Minimum experience required:

5 years of relevant experience in medical devices or pharmaceuticals, preferably within Regulatory Affairs or a related field; 5 years of experience managing others. 5 years’ experience in preparing submissions, including but not limited to product registrations and customer licensing for FDA, EU MDR, and other international markets.

- Abilities and skills required:

- Experience with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA, QSR/QMSR, ISO standards, and other applicable regulatory requirements.

- Proven track record of successful regulatory submissions.

- Experience in documentation and records administration.

- Must be able to travel and work in Burbank and in Valencia.

- Customer service experience and handling customer complaints.

- Must be able to communicate clearly and succinctly and effectively over the phone, videoconference, and in writing with various clients including regulatory agencies.

- Strong interpersonal skills, with the ability to communicate effectively at all levels of the organization.

- Excellent problem solving, prioritizing, and time management skills.

- Ability to lead and conduct internal, supplier, and customer audits.

- Strong attention to detail.

- Able to lift up to 50 lbs.

- Experience in design control, manufacturing, process development, quality assurance, quality control.

- Ability to work independently and in a team environment.

- Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.

- Certified Lead Auditor.

- Proficient in Microsoft Dynamics or equivalent ERP system, Microsoft Office Suite applications (Word, Excel, PowerPoint), Teams, SharePoint, and SmartDraw or equivalent flowcharting program.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Compensation details:

100000-140000 Yearly Salary