Regulatory Affairs Specialist

Regulatory Affairs SpecialistWe are seeking a detail-oriented Regulatory Affairs Specialist to join a growing medical device company in Kendall, FL. This individual will support regulatory compliance, product registrations, regulatory submissions, and technical documentation for medical devices marketed in the U.S. and internationally.This is a great opportunity for someone with 13 years of regulatory experience, or an early-career candidate with relevant education and a strong interest in building a career in medical device regulatory affairs.ResponsibilitiesPrepare and coordinate documentation for regulatory submissions, including FDA 510(k), PMA, and European Technical DocumentationCreate, maintain, and update regulatory documentation for medical devicesSupport FDA adverse event reporting and international vigilance reporting requirementsManage medical device registrations in applicable marketsCompile documentation for regulatory submissions, license renewals, and annual registrationsSupport the implementation of new regulatory standards and requirementsReview labeling, manufacturing, marketing, and clinical documentation for regulatory complianceCoordinate with regulatory agencies on defined mattersPartner with R&D, Engineering, Quality, Operations, Sales, and Marketing to support regulatory requirementsAssist in developing regulatory strategies for new products and product approvalsSupport internal audits and regulatory inspectionsStay current on applicable medical device regulations, standards, and regulatory requirementsQualificationsBachelors degree in Engineering, Regulatory Affairs, or a related technical/scientific field13 years of regulatory affairs experience preferred; strong entry-level candidates with relevant education or experience will also be consideredKnowledge of FDA regulations and medical devicesExperience with regulatory documentation and document controlStrong technical writing, organization, and attention to detailAbility to collaborate effectively across technical and non-technical teamsBilingual proficiency (English/Spanish)RAPS certification is a plusCandidates must be legally authorized to work in the United States. This position is not eligible for current or future employment visa sponsorship.This is an office-based position in Kendall, FL with a growing medical device organization. The company offers a collaborative environment with exposure to Quality, Engineering, R&D, and other areas of the business.The organization is continuing to expand its product portfolio and international presence, including markets throughout South America. This role provides an opportunity to gain broad regulatory experience while contributing to medical devices designed to support patients with serious injuries.This is a Contract to Hire position based out of Miami, FL.The pay range for this position is $33.65 - $40.86/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)