Regulatory Affairs Analyst Job Vacancy in Varex Imaging Salt Lake City, UT 84104 – Latest Jobs in Salt Lake City, UT 84104
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Company Name : Varex Imaging
Location : Salt Lake City, UT 84104
Position : Regulatory Affairs Analyst
Job Description : Our Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following duties described below.Roles and ResponsibilitiesKeeps abreast of medical device regulatory procedures, medical device safety standards and changesStrong working knowledge of FDA regulations, guidance documents, 93/42/ECC (MDD), EU 2017/745 (EU MDR), ISO14971, ISO13485, MDSAP, and other global regulatory requirements and standardsCompiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China CFDA, and othersHelps drive applicable requirements of IEC 60601-1 and related medical device safety standards into design requirementsProvides technical support, regulatory guidance, and oversight for Safety (UL) and EMC testing including EMC and Safety test plans, working with test lab/test sites, review and approve test reportsParticipates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materialsRecommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory complianceParticipates as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycleReviews and approves design outputsUses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and proceduresReviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and/or approvalAdverse event determination and reporting to FDA, EU, and other countriesHelps determine and facilitate Field Actions and RecallsCompiles Technical Files for EuropeParticipates in hosting/assisting with external audits from Notified Bodies, customers, and FDARequirementsBachelor’s Degree in life sciences, engineering, regulatory compliance3+ years of experience in regulatory compliance in the medical device industry and medical device safety standards3+ years of experience driving related medical device safety standards into design requirements3+ years of experience completing multiple submissions across health authoritiesExperience establishing or sustaining quality management systemsMicrosoft Office/ERP/QMS Software competencyBENEFITS Offered to our Employees: Medical Insurance (Select Health or Regence)Dental/Vision Insurance10 Paid Holidays plus 1 Floating Holiday of YOUR ChoiceA Generous Paid Time Off planEmployee Stock Purchase Plan (15% Discount)401K Plan through FidelityTuition Reimbursement (up to $7,500 per Year)Short/Long-Term Disability (Company Paid)Life Insurance (Company Paid)Annual Bonus potentialBenefits begin on your first day!!Take a Look at Our PERKS: ON-SITE Cafeteria, Nurse, Credit Union, and GymFree soda & coffeeCareer Advancement OpportunitiesEV Charging StationsSecured ParkingMeaningful work producing life-saving productsAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.Job Type: Full-timePay: From $70,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programFlexible scheduleFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offProfessional development assistanceRetirement planTuition reimbursementVision insuranceSchedule:Monday to FridaySupplemental Pay:Bonus payEducation:Bachelor’s (Preferred)Work Location: One location
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