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BD (Tissuemed Ltd) · 3 days ago

Manager, Regulatory Affairs

Salt Lake City, UT

Full-time

Onsite

Mid, Senior Level

6+ years exp

BD is one of the largest global medical technology companies in the world, and they are seeking a Regulatory Affairs Manager. This role is responsible for implementing regulatory policies and procedures, managing a team, and ensuring compliance for medical devices.

Health CareHospitalMedicalMedical Device

Responsibilities

Coordinates RA activities for direct reports

Manages RA responsibilities and functional goals which may consist of FDA and BD required filings and new information dissemination

Makes preliminary determinations regarding the appropriate US and/or International regulatory submission requirements for new or modified products

Reviews and approves documentation Change Requests, labeling artwork changes, recall and FDA inspection assistance, as defined by BD procedures

Facilitates FDA submission activities and creates 510(k) rationales, global submissions and/or rationales

Writes new product submissions, prepares and/or contributes to FDA and required BD reports, and ensures RA department support on new product teams

Keeps knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible

Acts as alternate liaison for quality system audits and inspections

Will develop global regulatory strategies

Supervises maintenance of US, CE, and international documentation

Involved with the coordination and management of EU MDR technical file audits; and supports other external and internal audits

Qualification

Regulatory Affairs experienceFDA submissionsGlobal regulatory strategiesMedical device quality regulationsProduct development processesMicrosoft Office proficiencyManagement experienceRAPS certificationAnalytical skillsCommunication skillsProblem-solving skills