Top Regulatory Affairs Executive jobs in Arizona
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
International Regulatory Affairs Manager
- HRPivot, Inc
-
Tucson, AZ
FULL_TIME
-
Company description:
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and sell the world's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart as bridge to transplant for patients suffering from biventricular heart failure The SynCardia Total Artificial Heart™ is available in two sizes to accommodate patients’ diverse physiologies. The Freedom Portable Driver™ allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant. The SynCardia Total Artificial Heart™ has been successfully used in over 2,000 patients and is the most widely used and extensively studied total artificial heart in the world. For additional information and label information, visit us at www.syncardia.com.
Position description:
SynCardia is looking for an energetic International Regulatory Affairs Manager. The successful candidate will be responsible for managing SynCardia’s international product registrations in Canada, Europe, and in the rest of the world. Specific tasks will include planning, preparing, managing, monitoring, and budgeting the Company’s international regulatory affairs projects: coordinating and working with regulatory consultants; and managing and preparing submissions to authorities in SynCardia’s international markets. To this end, the International Regulatory Affairs Manager will be working together with Regulatory Affairs, Quality, R&D, and Clinical Affairs professionals at the Company's Tucson site. Moderate travel is required..
Principal responsibilities:- Assist in the preparation of regulatory submissions and filings, such as applications, amendments, supplements, annual reports, deficiency letter responses, Form 483
- responses, warning letter responses, adverse experience reports, recall communications, license renewals, registrations, reports, correspondence, and telecommunications
- Gather, assemble, and prepare appropriate documents for submission supporting the EU and other international markets
- Independently research regulatory issues and/or information as directed
- Independently track and follow-up on Regulatory commitments to assure commitments are completed and maintained
- Prepare documents, as directed, for internal use or submission to regulatory authorities
- Support regulatory filing processes in collaboration with a multi-disciplinary professional support staff
- Independently monitor and improve tracking/control systems for regulatory documents
- Participate in Design Control meetings with Product Development to provide regulatory input
- Initiate action to prevent the occurrence of nonconformities relating to the product, process, and Quality System
- Identify and record potential problems relating to the product, processes, and Quality System
- Initiate, recommend or provide solutions through designated channels
- Other duties as assigned
- Provide regular updates to the Director of Regulatory Affairs and Company management on clinical International Regulatory Affairs statuses, plans, budgets, timetables, and bottlenecks
- Minimum of 5 years of International Regulatory Affairs experience gained in a similar position with at least 3 years in the cardiovascular device arena
- University degree from a top-tier academic institution in a relevant field
- Extensive knowledge of relevant government regulations, standards and guidelines
- Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player
- Proven track record of working in a dynamic, international environment
- Excellent written and spoken English
- Proven experience of successfully directing the efforts of diverse teams located across multiple locations/time zones is required
- Effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example
- Strong regulatory and business mind; he/she should be able to visualize future strategy while also outlining and driving tactics to complete the milestones to successfully execute that strategy
- Comfortable leading the execution of all aspects of International Regulatory Affairs including prioritization of projects
- Advanced experience and knowledge of ISO 13485, MDR, MDSAP & 21 CFR 820
- Excellent communicator who radiates compassion, integrity, and loyalty to SynCardia and its customers, partners, shareholders, and employee
A3fv7kJLjW - 3 Days Ago
Regulatory Affairs Associate
- VB Cosmetics, Inc.
-
Chandler, AZ
FULL_TIME
- Regulatory Affairs AssociatePosition Summary:With emphasis on cosmetic products and over-the-counter drugs for the region of North America (US/CAN), provides regulatory guidance and advice on regulato...
- 3 Days Ago
Regulatory Affairs Manager
- Tessenderlo Kerley, Inc.
-
Phoenix, AZ
FULL_TIME
- Company DescriptionTessenderlo Kerley, Inc. is a company of diverse businesses unified by shared values. We serve the agricultural, mining, industrial, and water reclamation markets with a broad range...
- 8 Days Ago
Regulatory Affairs Specialist II
- Spectrum Plastics Group, A DuPont Business
-
Tucson, AZ
FULL_TIME
- JOB PURPOSE: Provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will execute tasks and play a consultative role by partn...
- 1 Day Ago
Coord 1, Regulatory Affairs
- Intellectt Inc
-
Tempe, AZ
FULL_TIME
- Hello I'm Komal from Intellectt we have an opening for a Coord 1, Regulatory Affairs in Tempe, AZ. Please find the job details and description below and if interested You can reach me at komal@intelle...
- 12 Days Ago
Regulatory Affairs Specialist II
- XERIDIEM MEDICAL DEVICES INC
-
Tucson, AZ
FULL_TIME
- JOB PURPOSE: Provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will execute tasks and play a consultative role by partn...
- 1 Month Ago
Top Regulatory Affairs Executive jobs at Popular Companies
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Experis
-
Maplewood, MN
- Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Sr. Specialist, Regulatory Affairs
- Alphatec Spine
-
Carlsbad, CA
- The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and interna...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About Arizona
Arizona (/ˌærɪˈzoʊnə/ (listen); Navajo: Hoozdo Hahoodzo Navajo pronunciation: [xòːztò xɑ̀xòːtsò]; O'odham: Alĭ ṣonak Uto-Aztecan pronunciation: [ˡaɺi ˡʂonak]) is a state in the southwestern region of the United States. It is also part of the Western and the Mountain states. It is the sixth largest and the 14th most populous of the 50 states. Its capital and largest city is Phoenix. Arizona shares the Four Corners region with Utah, Colorado, and New Mexico; its other neighboring states are Nevada and California to the west and the Mexican states of Sonora and Baja California to the south and so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$286,751 to $469,122
Most Popular Cities in Arizona for Top Regulatory Affairs Executive Jobs
What does a Top Regulatory Affairs Executive do?
Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020