Sr Regulatory Affairs Specialist
Acara Solutions, An Aleron Company - Brea, CA
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Acara Solutions is looking for a Sr. Regulatory Affairs Specialist in Brea, CA. This position is a contract position lasting 6-8 months. Pay: $45 hourlyPosition Overview:The Sr. Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. This position will be based at our HQ in Brea, CA and will require someone work on-site 3x per week.ESSENTIAL DUTIES AND RESPONSIBILITIES:Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met. Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark. Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the companyCreates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhancedTechnical writing of procedures and/or SOPs that link to the regulatory operations Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projectsDevelops and coordinates regulatory strategies and regulatory plansResponsible for the implementation of regulatory strategies and ensures timely registration of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and existing products in regulated markets (i.e. US, Canada, Asia-Pac, LATAM, Russia/CIS, China, and MEA-T)Prepares documentation that is complete, accurate, and on time.Coordinates, prepares, and maintains regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regionsWork directly the regions (inter-company partners, distributors, in-country consultants, commercial partners, etc.) to fulfill regulatory requirements for product registration purposesMaintains approvals/licenses/authorizations for existing marketing authorizationsComplete regulatory assessments and audits of product, manufacturing, Quality Management System (QMS) and labeling changes to assess impact to the user/patient, regulatory reporting, and compliance to regulationsManage regulatory projects consistent with the company goalsIdentifying, communicating, and solving any regulatory issues that may ariseJOB REQUIREMENTS:Bachelor's degree in a scientific discipline4-6 years of work experience in RA role within Medical Device industry or 2 years work experience with Master's DegreeSKILLS & QUALIFICATIONS:Master's degree in Regulatory Science or RAC certification preferredExperience authoring 510(k)s, PMA, Health Canada and/or EU Technical File submissions for medical devices preferredDemonstrated experience serving as lead RA representative on cross-functional teams supporting new product development; SaMD experience a plus. Must possess in-depth knowledge of design control requirements and experience assessing product and/or manufacturing changes for regulatory impactExperience reviewing and approving marketing, advertising, and promotional materials a plus. Successfully manage multiple projects simultaneously and within a fast-paced environment Problem-solving skills and creativityWorks well in a cross-functional team; will speak up to provide regulatory guidanceSolves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of informationEnjoys being a resource for colleagues with less regulatory affairs experienceOrganizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suiteEnthusiastic self-starterExcellent verbal, written, and interpersonal skills (explains difficult or sensitive information; works to build consensus)Must be comfortable dealing with ambiguity, relying on critical thinking to accomplish project goalsHighly organized with a detail-oriented mindsetPortray flexibility and multi-tasking in a dynamic environment with changing prioritiesInterpret and provide guidance on regulations from various countriesRead and interpret documents such as safety rules, operating and maintenance instructions, and procedure manualsWrite routine reports and correspondence
Created: 2024-10-04