Apply on Employer Site

Diality · 15 hours ago

Post-Market Regulatory Affairs Specialist

Irvine, CA

Contract

Onsite

Mid Level

$62/hr - $70/hr

3+ years exp

Diality is a company focused on medical devices, and they are seeking a Post-Market Regulatory Affairs Specialist. This role involves maintaining product compliance in clinical settings, managing regulatory notifications, and collaborating with cross-functional teams on product changes and reporting.

Health CareHealth DiagnosticsMedicalMedical Device

Hiring Manager

Elizabeth Chavez

Responsibilities

A strong candidate must have Medical Device IDE (clinical trial) experience and understands the FDA expectations for design changes to the medical device and, thereby with understanding of this need, this individual contributor assesses the potential impact of the changes to the product being used in clinical study and collaborates with Leadership in Quality, Medical Affairs, Engineering team on exploratory pathways and options as next steps

Responsible for Medical Device Reporting, preparing FDA-Form 3500A, on a case-by-case basis

Represent Regulatory Affairs function in the Product Issue Review Board meeting

Support Quality Systems projects and activities such as, but not limited to, the following:

Complaint Handling

Product Recalls and Corrections

Product adverse event reporting

Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders

Any required support for pre-market regulatory responsibilities, such as, evaluation of changes from impact perspective, and compliance checks

Qualification

Medical Device IDE experiencePost-Market regulatory experienceISO 13485 knowledgeFDA regulations knowledgeRegulatory Affairs Certification (RAC)Technical writing skillsMicrosoft Office proficiencyInterpersonal skillsProblem-solving skillsCommunication skillsOrganizational skills

Required

A minimum BA/BS Degree with at least 3-5 years of regulatory affairs experience required in medical device industry

Experience with medical device IDE trials is required

Post-Market medical device regulatory experience required

Broad based technical awareness and exposure to functions such as Engineering, Operations, Quality, Marketing, Medical/Clinical Affairs, etc

General working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations

Good knowledge of Clinical evaluation and investigation of medical devices

Excellent interpersonal skills including ability to interact with high degree of diplomacy

Excellent problem-solving skills, applied thinking skills and technical writing skills

Excellent communication and organization skills required

Ability to work in a fast-paced, technically challenging environment where drive is critical to success

A self-starter who is able to drive projects, can assertively outline regulatory risks to cross-functional team, and has a 'roll up sleeves' positive attitude

Expertise in Microsoft Office applications, such as MS Word and Excel

Preferred

Certification in regulatory affairs (RAC) preferred

Strong preference for a well-rounded person with experience in a start-up medical device environment with a combination of regulatory and clinical skill set