Regulatory Affairs Associate

RXinsider LTD.; California (MO); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

HSA/FSA options

Life Insurance

Disability Insurance

401(k) plan

Job summary

Abbott is seeking a Regulatory Affairs Associate in Sylmar, CA for 7 months of 100% onsite work. Responsibilities include filing regulatory applications with U.S. and international authorities, authoring PMA supplements, and supporting EU MDR documentation updates.

A bachelor’s degree in a scientific field and at least 1 year of regulatory experience in medical devices are required. Experience with PMA supplements, EU MDR, and FDA 21 CFR guidance is preferred.

Qualifications

• Requires a bachelor’s degree in a scientific or related discipline.
• At least 1+ years of direct regulatory experience in the medical device field.
• Exposure to PMA supplements and EU MDR requirements is desirable.
• Familiarity with FDA PMA guidance documents and 21 CFR regulations.

Responsibilities

• File regulatory applications and support interactions with FDA and international authorities.
• Author PMA supplements, 30-day Notices, Real-Time Reviews, and EU submissions.
• Review engineering study protocols/reports and validation studies for regulatory impact.
• Review and approve manufacturing/design changes for Class III implantable devices under FDA/EU MDR requirements.

Skills

Regulatory affairs

FDA PMA

EU MDR

Class III implants

Regulatory submissions

Documentation review

Notified Bodies

Education

Bachelor's degree in a scientific field

Job description

Title: Regulatory Affairs Associate

Location: Sylmar, CA

Duration: 7 Months

100% Onsite

Summary

Responsible for filing necessary regulatory applications and supporting interactions with U.S. and international regulatory authorities for products requiring governmental approval. Authoring and submitting U.S. PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body submissions.

Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements.

Requires a bachelor's degree in a scientific or related discipline and at least 1+ years of direct regulatory experience in the medical device field.

Recent Experience With Class III Implantable Medical Devices Preferred.

Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745) requirements are desirable.

Working knowledge of FDA PMA guidance documents, 21 CFR regulations, and EU regulatory frameworks.

Relies on experience and judgment to plan and accomplish assigned goals. Performs a variety of tasks with guidance as needed. Demonstrates accountability for deliverables and ability to follow through on submissions and regulatory activities. A moderate degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans


• Dental Plan


• Vision Plan


• Health Savings Account (for High-Deductible Health Plans)


• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)


• Supplemental Life Insurance


• Short Term Disability (coverage varies by state)


• Long Term Disability


• Critical Illness, Hospital coverage, Accident Insurance


• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance


• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.