A Regulatory Consultant ensures that companies adhere to applicable government regulations. Working for a variety of industries, these consultants undertake the following job duties mentioned on the Regulatory Consultant Resume – ensuring the company employees are well-acquainted with the applicable regulations, consulting with staff on different projects, ensuring the production methods or design plans comply with regulations, developing policies that are designed to maintain regulation compliance, establishing procedural guidelines, gathering reports and paperwork, and submitting materials to government agencies.
Even while the industries may vary and regulations change as per the working standards, the needed skills to execute them are common and include the following – strong communication and interpersonal skills, the ability to come up with proper solutions, strong knowledge of understanding and addressing issues relating to regulation compliance, and analytical skills. One needs to have a degree in relevant areas such as finance or healthcare to earn this post.
Summary : Multi-disciplined professional with 25+ years of experience in energy, environmental, chemical, legal and engineering assignments. Fifteen-plus years multi-national project management experience Business skills include market analysis, program planning and development, budgeting, and training, auditing programs, permitting, and managing assets.
Skills : Training, Auditing, Project Management, Problem Solving, Cost Savings.
Description :
Contacted for a Federal project to restore compliance following activities resulting in a multi-million dollar fine and federal probation for a company's reoccurring violations of the clean water act.
Developed of a 12 month plan to with accountability and timelines requirements to restore compliance.
Planned was utilized by attorneys in Federal Court to negotiate terms and conditions of Federal probation.
Compliance plan was presented to Federal Prosecutor and Federal Magistrate Additional responsibilities included policy and program development, JSA / JHA evaluations for all operating procedures, training and permit review / modifications.
Worked with company's Board of Directors, as well as executive management staff to prepare company for probation meetings and inspections.
Initiated several manufacturing process changes (water filtration, fume collection, process re-piping) to eliminate possibility of incident reoccurrence.
Represented company was placed on 2 years Federal probation.
Experience
10+ Years
Level
Senior
Education
MS
Regulatory Consultant Resume
Summary : Certified regulatory professional with multidisciplinary experience encompassing pharmaceuticals, biologics and medical Devices. Well versed in devising regulatory strategy, authoring and editing documents including INDs, NDAs, Annual Reports, 510K, Protocols, Informed consent etc. Experienced in interfacing with cross functional teams and communicating with FDA.
Skills : Administrative Assistant, Data Entry, Accounts Payable.
Description :
Developed US regulatory submission path for a medical device for the unchartered market and providing regulatory input to product lifecycle and determining submission and approval requirements.
Educated and guided team through the FDA compliance to meet regulatory requirements including in depth product and business plan evaluation to decipher regulations.
Formulated a sound regulatory strategy to lead implementation of submission to FDA and participated in efficient and competitive product development of medical device.
Developed and submitted of 510(k) for Class II medical device and prepared responses to FDA for requests for additional information.
Served as a Regulatory representative to the executive team, and provided regulatory support strategy for new products/therapies and modifications to existing products.
Documented and maintained oral and written communications with FDA and regulatory files, records, and reporting systems.
Development of Quality System from the ground up - including SOPs, Work Instructions, and Forms/Templates for the product development life cycle, software development life cycle, user manual and document control.
Experience
7-10 Years
Level
Management
Education
Certificate In Clinical Research
Regulatory Consultant Resume
Headline : To employ with a company, which has room for future growth and expansion, and to seek education for training that is necessary to meet the needs of my employer.
Skills : Regulatory Affairs, Quality Management Systems, ISO 13485, ISO 13485, ISO 9001, MDD 93/42/EEC, MDD 93/42/EEC, GMP, CE Marking, 510.
Description :
Oversaw all aspects of project implementation to deliver regulatory approvals on time.
Worked closely with a variety of internal Regulatory teams and Network Engineering teams to oversee FCC/FAA compliance.
Understood projects technical details (Wireless Network Cell Site Development and government rules and regulations etc).
Uncovered and assessed project risks.
Assessed need for AM detune, Station Notification, Pre and or Post Measurements and order work through approved vendors.
Reviewed tower modifications to determine need for NEPA, SHPO, THPO or other agencies affected by tower expansion.
Ensured compliance with Migratory Bird Act as it applies to tower modifications.
Experience
5-7 Years
Level
Junior
Education
MS
Regulatory Consultant Resume
Headline : Executive level healthcare leader Team Builder Motivator Career recipe of civilian and military nursing clinical leadership opportunities Navy Nurse Corps Officer achieved rank of Commander (0-5) Patient centric nursing expertise Quality, risk, and patient safety expertise Master of Science degree in Nursing (Nurse Administrator) Missouri RN Licensure.
Implemented standards and regulatory compliance activities for a > 5,900 FTE organization.
Focused subject matter expert on patient safety and compliance needs of 15 inpatient nursing floors, 44 on-site ambulatory clinics and 11 satellite medical / dental clinics.
Created a culture of quality and safe care through risk reduction for > 1.3 million annual patient visits.
Initiated a continuous readiness process, trending risk management and accreditation compliance tracer activity data to identify and fulfill educational needs of Medical Center leadership and staff.
Spearheaded Joint Commission survey activities of a 13-member action team to implement corrective action plans, gaining 100% standards compliance within 45 days.
Launched the first comprehensive Periodic Performance Review process that included Medical and Nursing Executive committee participation.
Completed compliance assessment of >1000 elements of performance within 279 standards and reported results to the Joint Commission in < 90 days.
Experience
5-7 Years
Level
Executive
Education
MS
Regulatory Consultant Resume
Objective : To obtain an executive management position within a Medical Device Manufacturer's Quality organization where I am able to utilize my leadership and management experience. To utilize to my quality assurance and regulatory knowledge, experience and skills necessary to lead an organizations in the design, implementation, and maintenance of a Quality Management System that is not only regulatory compliant, but also sustainable for the success of the business.
Skills : Microsoft Word, Managing Skills.
Description :
Provided detailed analytical support for complex financial and administrative issues that affected the regulatory requirements and policy of the company.
Prepared, evaluated and advised on financial information for statutory compliance and rate filings which directly impacted return on equity and return on assets.
Performed tariff administration and addressed various issues concerned with corporate separation and deregulation issues.
Actively participated in contract negotiations with special customer groups.
Coordinated Annual Information Filing and adjustments.
Prepared quarterly Capital Structure on a functionalized basis and reported on the company's Return on Rate Base and Common Equity.
Prepared Nationwide Programmatic Agreement (NPA or PAL) letters for customers to ensure they are in compliance with tower modification document requirements.
Experience
2-5 Years
Level
Junior
Education
MBA In Accounting
Regulatory Consultant Resume
Headline : Reliable and highly accurate Quality Assurance professional with over 13 years experience in a manufacturing and highly regulated industry. Works well under pressure and with others. Values an organization that embodies quality, knowledge, experience and education.
Skills : Telepro, TIMS Tariff Filing System, Cingulinc Lease Database, Treev, Quickbase, ITS, VZREG , Networkflow, Oracle, Filenet, Sharepoint, CTS, Norad, Excel, Word, Access, PowerPoint, WordPerfect 6.0, Microsoft Outlook, SAP, Frequency Application Management Systems, Remedy, Google Earth Pro, State Atlas.
Description :
Responsible for assuring that VZW remains in Compliance with its responsibilities and legal obligations as a Federal Communications Commission licensee.
Responsible for FCC Compliance for all cellular, CDMA/850 MHz, PCS/1900 MHz and LTE/700 MHz sites and markets licenses through extensive use of various systems such as the Universal Licensing Systems (ULS), Antenna Structure Registration (ASR) and Regulatory Database (VZReg).
Reviewed collocations and managed towers for FAA, FCC and NPA compliance prior to Construction & In-Service start and integration.
Issued Site Releases to Construction & In-Service for New Builds, Modifications, COWs and In-Building Systems.
Responsible for keeping an open communication with the RF Engineering to make sure the sites are properly developed.
Filed FAA Study and FCC ASR Registrations.
Reviewed Digital Contour plots for FCC CGSA compliance and update FCC Station Records.
Experience
5-7 Years
Level
Executive
Education
GED
Regulatory Consultant Resume
Objective : Results oriented savvy international business professional with expertise in pharmaceutical and consumer products regulatory affairs, data integrity auditing clinical trials data, stability, and batch records, ICH GCP certificate issued by ACRP, eCTD submissions, information management, regulatory systems administrator, CAPA certified, well versed in ICH GMP and ICH GCP.
Explained Florida Statutes regarding landsales, condominiums and mobile homes to developers, association members and unit owners.
Solved problems for license holders while balancing the needs of the agency.
Answered questions to satisfy concerns regarding Florida laws and regulations to applicants, license holders and city and county officials.
Explained applications and the necessary processes to both license holders and applicants.
Served on a committee of three to set up training for new employees.
Took payments for applications and renewed licenses and explained fees.
Took supervisor calls when other agents could not satisfy the customer.
Experience
2-5 Years
Level
Junior
Education
Masters Of Business Administration
Regulatory Consultant Resume
Summary : CMS (Federal), State, Joint Commission, NRC, ClIA, CAP and all regulatory bodies. Responsible for keeping Missouri Baptist Medi cal Center compliant with all regulatory bodies. Successfully took this 500 bed facility through Joint Commission surveys. Very knowledgeable about all professional scope of practices. Very knowledgeable in writing plan of corrections. Very knowledgeable in audit and tracer activity.
Skills : CMS Surveys, Licensure Surveys, EMTALA Investigations, IJ Investigations. Project Management For Large 500 Bed Facility To Prepare For TJC Survey., Nursing, Business Management.
Description :
Responsible for facility compliance with all CMS, State and Joint Commission rules, regulations and standards.
Wrote all plan of corrections.
Worked on root cause analysis and implement action teams.
Responsible for all the regulatory agencies that enter into my 489 bed facility.
Trained by CMS in Baltimore, MD to be a hospital surveyor for the State of Missouri.
Kept current on all regulatory changes that affect my organization.
Maintained New Build and Modification compliance for FCC AM guidelines.
Experience
10+ Years
Level
Senior
Education
MBA
Regulatory Consultant Resume
Summary : Licensed long term care administrator with 26 years of experience in leadership and management of services for older adults. Experienced includes independent living, HUD senior housing, assisted living, long term care consulting, acute care, home and community based services, project development, budget development, strategic planning, strategic financial planning, operations planning, market feasibility, and senior living construction design.
Skills : SEO Copywriting, Wordpress Content Management.
Description :
Authored Material Safety Data Sheets.
Determined appropriate hazard assessment according to country/region, translation of documents English/Franch.
Independently assessed product compositions or chemical formulations to applicable country regulations.
Researched chemical, physical and safety hazards and properties of components to make appropriate MSDS classification for global regulations.
Understood and adhered to global EHS regulations and have a clear understanding of newest MSDS regulatory requirements.
Translated documents from English to French with emphasis of the French regulatory requirements.
Assisted with the coordination of all external body surveys (The Joint Commission, CARF, CMS etc.).
Experience
10+ Years
Level
Senior
Education
GED
Regulatory Consultant Resume
Headline : To obtain a Regulatory Consultant position where I can use my knowledge of United States and International Regulatory Affairs requirements and technical writing abilities to the fullest potential to achieve revenue growth and positive market approvals in a team or independent environment.
Skills : Planning Skills, Consultant.
Description :
Served as team leader for an inbound call center, supervising and motivating a team of thirteen employees.
Responsible for sponsoring, leading, and facilitating call center process improvement teams.
Coordinated the interviewing, hiring, and training of customer service representatives.
Administered employee performance management by diagnosing improvement opportunities, providing effective feedback, coaching, training, professional development, and corrective action plans.
Awarded two Davis Productivity Certificates of Commendation for my part in reducing call volume and continuing education rule revisions.
Provided oversight for Orlando Health Policies and Procedures and compliance with National Patient Safety Goals.
Supported development and maintenance of unit based performance improvement indicators database.
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