Regulatory Compliance Manager Resume Samples

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.

Experience

7-10 Years

Level

Management

Education

MS

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.

Experience

7-10 Years

Level

Management

Education

GED

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.

Experience

5-7 Years

Level

Executive

Education

MBA In Health Care Management

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.

Experience

5-7 Years

Level

Executive

Education

GED

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.

Experience

10+ Years

Level

Management

Education

Business 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.

Experience

7-10 Years

Level

Management

Education

Master Health Administration

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.

Experience

2-5 Years

Level

Executive

Education

MS

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.

Experience

10+ Years

Level

Senior

Education

MS

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.

Experience

10+ Years

Level

Senior

Education

GED

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.

Experience

7-10 Years

Level

Management

Education

B.B.A.