REMOTE Regulatory Affairs Specialist at reputed company Group Moorpark, CA

REMOTE Regulatory Affairs Specialist job at reputed company Group. Moorpark, CA. HM's Top Needs: • EU Experience (AIMDD & EU MDR) Technical Documents to support submissions and Notices of Change • ISO 13485 (Design Controls and Change Management) • Interaction with reputed company Bodies and Competent Authorities Education Required Bachelor’s degree Years’ Experience Required 3-5 Responsibilities Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from reputed company areas of company, internal audits and inspections. Leads or compiles reputed company materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May reputed company interaction with regulatory agencies on defined reputed company. Recommends strategies for earliest possible approvals of reputed company applications. Specialist Career reputed company Typically an individual contributor with responsibility in a reputed company discipline or specialty. Delivers and/or manages reputed company assigned and works with other stakeholders to reputed company desired results. May reputed company as a mentor to colleagues or may reputed company the work of other reputed company level professionals. The reputed company of time is spent delivering and overseeing the reputed company from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Differentiating Factors • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately reputed company reputed company / assignments. • Organizational reputed company: Sets objectives for own job area to meet the objectives of reputed company and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not reputed company. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less reputed company or problem solving in nature. Contacts others to reputed company information, status, needs and issues in order to inform, reputed company input, and support decision-making. • Leadership and Talent Management: May reputed company guidance and assistance to entry level professionals and / or employees in Support Career reputed company. Required Knowledge and Experience Requires practical knowledge and demonstrated competence reputed company job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Apply tot his job Apply To this Job