Job Location - Moorpark, California, 93021 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 Notified Bodies and Competent Authorities Education Required Bachelor’s degree Years’ Experience Required 3-5 Responsibilities Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all 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 direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Specialist Career Stream Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while 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 complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects 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 complex. 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 complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience Requires practical knowledge and demonstrated competence within 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. Seniority level Mid-Senior level Employment type Full-time Job function Legal Industries IT Services and IT Consulting #J-18808-Ljbffr IntePros
...Get Paid, Have Fun, Make a Difference!~Located in Moncure , near Pittsboro . ~Summer and year-round opportunities. ~Counselors assist campers in all aspects of self-care (dressing, bathing, eating, grooming, toileting) and other areas of daily living. ~Implement...
...for a CDL Class B driver responsible for operating bulk trucks and installing blasting products at construction sites, mines, and quarries while maintaining equipment. The position involves a blend of driving (40%) and physical labor (60%) under various weather conditions...
Pet sitter, this Friday th Sunday in home , and also at the end of month , possible 3 to 5days Small dog ,Please visit to view full details and to apply. Lots of jobs to choose from!
...We are seeking a Construction Project Engineer to join our team in San Antonio, TX. This role is ideal for a candidate with industrial construction project experience who is looking to advance their career in a dynamic and fast-paced environment. You will support...
Office Depot Office Max , Delivery Driver , Class BDenver, COLORADO , Pay: 16.50Please apply at http://jobs.officedepot.com/job/6996673/delivery-driver-denver-co/Responsibilities:The Delivery Specialist (Driver)is responsible for delivering customer orders in a ...