Regulatory Compliance Manager Resume Samples

A Regulatory Compliance Manager is a professional hired to ensure the appropriate licensing, marketing, and legal compliance of a range of medical and pharmaceutical products, are safe and efficient. While the job duties vary based on the working industry, certain core duties are identified on the Regulatory Compliance Manager Resume as – ensuring the company’s products comply with the regulations of the regions, keeping up to date with national and international legislation, guidelines, and customer practices, collecting and collating scientific data, developing and writing clear arguments and explanations, preparing submissions of license variations and renewals, advising scientists and manufacturers on regulatory requirements, and reviewing company practices and providing advice on changes to systems.

To get into this field, one needs to have – a solid understanding of both legal and scientific matters, the ability to grasp new concepts quickly and to assimilate and evaluate scientific data, written and oral communication skills, and familiarity with commercial software. Job applicants are expected to have a good honors degree in fields such as physical, mathematical, applied, and medical science or a related area.

Regulatory Compliance Manager Resume example

Regulatory Compliance Manager Resume

Summary : Seeking a Regulatory Compliance Manager position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.

Skills : Microsoft Office, Word, Excel, Outlook, Fosse, SalesPro, PeopleSoft, WebEx, SalesForce, SalesPro, Fosse, Marsha.

Description :

    1. Presented Regulatory Compliance Manager with seven years of experience in the medical device industry.
    2. Provided regulatory support for new product development by outlining submission requirements for new products.
    3. Responsible for providing regulatory assessment and approval of product design and manufacturing process changes.
    4. Determined if changes require 510(k) submission, Notified Body, or customer approval.
    5. Prepared regulatory submission to EU Notified Body for class II device approvals.
    6. Effectively prioritized and delegate multiple competing tasks while supervising quality department employees.
    7. Maintained a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
MS


Regulatory Compliance Manager Resume

Summary : Experienced and goal-oriented Manager with a demonstrated track record of leading the preparation and analysis of financial reports to summarize and forecast financial position. Dynamic and reliable with over seven years of compliance, AML/BSA review, casino revenue audit, financial review and consulting experience. Core competencies include: Financial Analysis Budgeting Regulatory Compliance Cost Reductions Efficiency Improvement BSA/AML Expert Variance Analysis Process Implementation SOX Compliance.

Skills : ACL, Microsoft Office, Process Improvement.

Description :

    1. Regulatory oversight of the online gaming division of Caesars Entertainment for Nevada, New Jersey and Delaware.
    2. Implemented standardized procedures enterprise wide to allow better review of suspicious activity reporting and compliance with BSA/AML FinCEN standards.
    3. Developed, produced and enhanced risk reports for all business units.
    4. Tested the design and effectiveness of internal controls by completing walk-throughs of complex business processes.
    5. Verified that company controls were in compliance with established policies by proactive auditing.
    6. Maintained detailed administrative and procedural processes to improve accuracy and efficiency.
    7. Coordinated meetings with other department managers and served as main liaison between operations and regulatory bodies.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
GED


Regulatory Compliance Manager Resume

Headline : Hardworking, organized, Regulatory Compliance Manager professional with a proven background delivering sensible business technology solutions on time and under budget while working as a team member or team leader.

Skills : FEMA Emergency Management Institute: IS-00100, IS-00200, IS-00700, Harvard ManageMentor.

Description :

    1. Trained the Quality department in ISO 9001:2008 methodology and DNV GL accreditation.
    2. Responsible for managing all organizational certifications and accreditations; survey preparation and response, gap analyses, and auditing.
    3. Audited new services on- boarded.
    4. Ensured the organization was updated of regulatory changes and ensured appropriate organizational responses.
    5. Performed and wrote job evaluations, employee performance goals planning and evaluation, and maintaining department budget.
    6. Developed organizational change management strategies.
    7. Responsible for remediation of FDA, CE MDD, ISO 13485, and CMDR audit findings.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Executive
Education
Education
MBA In Health Care Management

Regulatory Compliance Manager Resume

Headline : Polished, proven professional who specializes in developing and implementing processes to achieve maximum results for companies in the information/compliance management areas.

Skills : Windows, Internet Explorer, MS Office, Excel, Outlook, Publisher, Quickbooks, Oildex, Cortex, ADP.

Description :

    1. Managed the Regulatory Compliance group for the National Office of Risk Management of McGladrey & Pullen and RSM McGladrey.
    2. Monitored, reported on and implemented regulatory changes for National Accounting firm of over 7,000 employees.
    3. Instituted automated procedures using PeopleSoft functionality to increase efficiency.
    4. Developed processes for improving CPE and licensing information tracking into Learning Management System.
    5. Developed processes to track compliance with licensing and CPE requirements, both state and federal.
    6. Process improvement efforts resulted in reduction of staff by 1 FTE.
    7. Streamlined firm licensing process to ensure compliance with applicable regulations.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Executive
Education
Education
GED

Regulatory Compliance Manager Resume

Summary : Ensuring that the portfolio and individual communities meet the established operational, financial, and business performance goals by inspecting properties, reviewing the financial, market, and operational reports, and developing and implementing appropriate action plans to achieve results.

Skills : Microsoft, Kronos, SAP, Peoplesoft.

Description :

    1. Managed major organizational change in the EHS culture to support new ownership growth strategy.
    2. Implemented a comprehensive awareness training program which resulted in 100% reduction in OSHA incidents.
    3. Engaged employee participation in Root Cause Analysis and corrective action procedures.
    4. Provided leadership in developing management systems to comply with FDA's GMP and HACCP requirements.
    5. Managed PSM/RMP program inclusive of training as triggered by high risk chemical per OSHA/EPA requirements.
    6. Managed site security plan triggered by FDA, DOT, Homeland Security and state controlled chemicals and equipment.
    7. Developed and implemented a seamless compliance tracking and reporting system.
Years of Experience
Experience
10+ Years
Experience Level
Level
Management
Education
Education
Business Management

Regulatory Compliance Manager Resume

Summary : Identifying opportunities to increase accuracy and optimize resources and develops/recommends/implements solutions, and also performing economic analysis, calculation of costs and benefits, evaluation of economic tradeoffs, and sensitivity analysis.

Skills : Analytical/Critical Thinking, Compliance Monitoring Programs, Contract Administration, Contract Negotiations, HIPAA, Privacy And Security, Investigations, Lean Six Sigma, Legal Knowledge, Regulatory Compliance, Risk Management.

Description :

    1. Planned and administered complex market conduct, claims, provider disputes and financial audits.
    2. Supervised and oversee all phase's corrective action planning relating to regulatory deficiencies.
    3. Negotiated resolution of issues from market conduct exams, provider disputes and regulatory inquiries.
    4. Investigated and responded to third party hospitals, providers and medical groups and state inquiries.
    5. Drafted and submitted comment letters to regulatory agencies, hospitals and delegated provider and medical groups.
    6. Communicated and justified findings, recommendations, remediation and corrective actions to regulatory agencies.
    7. Cultivated and maintained strong and effective relationships with internal business partners and external providers, hospitals, medical groups and regulatory agencies both orally and in writing.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
Master Health Administration

Regulatory Compliance Manager Resume

Objective : To obtain a director level Regulatory Compliance Manager position in a commercial and/or government contracting function where my specialized knowledge and experience can best be applied in meeting the goals and objectives of the company represented.

Skills : Management, Customer Service, Team Building, Inventory, Payroll, Scheduling.

Description :

    1. Assisted outside legal counsel efforts during company acquisition, performing in a paralegal role.
    2. Established and implemented office policies and standard work procedures.
    3. Responsible for managing telecommunications contracts and renewals.
    4. Negotiated company insurance policies and rates.
    5. Prepared company stock option plans (ESOPs).
    6. Assisted CFO with financial forecasting and budgeting.
    7. Established banking and investor relationships.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
MS

Regulatory Compliance Manager Resume

Summary : Thirty plus years Regulatory Compliance Manager experience with strengths in customer service, customer/Public relations, plus work planning and organization. Applicable skills include, but are not limited to, excellent organization and communication skills, 10-key, Excel, data entry, computer experience, working experience in office software, coordinating internal and regional projects for new products and services to markets for billing and customer service plus accounting knowledge.

Skills : MS Office, Planning Skills.

Description :

    1. Directed all aspects of the drug sample program, ensuring compliance with the Prescription Drug Marketing Act (PDMA) and other applicable state and federal regulations.
    2. Monitored sample inventories, including individual sales representative stock; documented variances, theft and losses.
    3. Generated all PDMA/state required sales promotion expense reports.
    4. Developed and executed standard operating procedures (SOPs) for sample management and state reporting.
    5. Liaised, as first point of contact, with sales representatives, internal department personnel, government officials and outside vendors.
    6. Facilitated and tracked employee PDMA training.
    7. Spearheaded deployment of a new automated sample program, working in close collaboration with IT, sales, marketing, QA and regulatory personnel to successfully deliver the project within time and budget targets.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
MS

Regulatory Compliance Manager Resume

Summary : Regulatory Compliance Manager with over 10 years of professional accounting and audit experience including Big Four Public Accounting, SEC Financial Reporting, Internal Audit, Regulatory Compliance and University Lecturer.

Skills : Proficient In Microsoft Outlook, Excel, Word, & PowerPoint., Proficient In The Use Of The EPA GHG Calculation Spreadsheet.

Description :

    1. Supervised regulatory staff at multiple sites.
    2. Established and executed company policies to maintain compliance with Good Clinical Practices.
    3. Prepped and submitted study regulatory documents to IRB and Sponsor.
    4. Created and maintained Trial Master Files.
    5. Maintained training logs and maintained staff certification regarding GCP's, EDC, IATA, etc.
    6. Reviewed and submitted protocol deviations as needed to the IRB and Sponsor.
    7. Served as main contact for monitor's and facilitated their visits.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
GED

Regulatory Compliance Manager Resume

Summary : Regulatory Compliance Manager Professional experience in Employee Relations, Recruiting, Onboarding/Retention, Leadership Development, Training, Succession Planning, Performance Management. Safety and Regulatory Compliance. Experience includes Mining, Manufacturing and Retail/Customer service.

Skills : Project Management, Leadership.

Description :

    1. Hired to join a team of three compliance managers.
    2. Responsible for state regulatory issues arising through the mortgage banking and broker licensing for GE Capital Mortgage Services, Inc.
    3. Absorbed the responsibilities of the other three compliance managers while developing technology solutions to manage the mortgage servicing and origination licensing and reporting for annual regulatory audits.
    4. Established and maintained relationships with the various state regulatory agencies and represented GE Capital Mortgage Services as an active member of the American Association of Residential Mortgage Regulators.
    5. Managed all customer complaints when referred by state regulatory authorities.
    6. Responsible for training employees in compliance matters.
    7. Acquired Six Sigma Green Belt.
Years of Experience
Experience
7-10 Years
Experience Level
Level
Management
Education
Education
B.B.A.