Regulatory Affairs Manager Resume
Summary : With nearly twelve years of experience in medical devices industry; have been able to competently deliver and execute on innovative regulatory strategies to provide excellent regulatory pathways to various cross-functional project teams towards obtaining worldwide regulatory clearances and approvals on state of the art medical devices.
Skills : Microsoft Office - Word, Excel, Powerpoint And Access, Adobe Forms.
- Streamlined regulatory processes to sector procedures and global regulatory requirements.
- Lead a stagnant regulatory submission project through strategy to address agency concerns.
- Restructed the Technical Documentation to represent product families.
- Distributed BY product families into overall system portfolio.
- Provided regulatory guidance to the business on key initiatives, projects and Review.
- Translated and prioritized projects to align with overall business goals and objectives.
- Lead regulatory team to understand challenges and help facilitate aggressive global strategies to expedite time to market.
Master Of Biomedical Engineering
Jr. Regulatory Affairs Manager Resume
Objective : Highly qualified Regulatory Affairs Manager with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and would excel in the collaborative environment on which your company prides itself.
Skills : Regulatory Affairs - Medical Products, Quality Assurance, IVDs, Cell Therapy Products.
- Developed and maintained documentation to track proposed legislation through the legislative process and compare/contrast similar legislation.
- Monitored and regularly updated management on proposed legislation affecting operation.
- Managed the affairs of a public board of directors for three separate public charter schools.
- Ensured that the boards remain in compliance with the State Open Door Laws.
- Managed the regulatory affairs of 19 campuses.
- Monitored the policies of and work with officials of federal and state accrediting agencies to ensure resident and distance education campuses.
- Complianced with agency accreditation standards.
Sr. Regulatory Affairs Manager Resume
Summary : Seven years of Management and Supervisory duties for contracting staff for the EPA's regulatory registration contract. Twelve years working in the area of Regulatory Review and Compliance. Nine years of experience as Regulatory Records Reviewer/Processor for the Environmental Protection Agency's (EPA) Pesticides Registration Division to include the Processing of pesticide registration applications and its distributing parts.
Skills : 27 years experience in medical regulated industry 19.
- Identified of required submission elements.
- Identified of timelines and costs.
- Ensured the proper data is developed.
- Developed accurate submission containing all required elements.
- Responsible for tracking and monitoring process of submissions.
- Developed and maintained an in depth, on-going knowledge of EPA pesticide regulations (FIFRA) and requirements for submission of registration applications and required label changes.
- Submited Toxic Release Inventory reports (TRI's).
Regulatory Affairs Manager I Resume
Summary : C/C++, Visual Basic, Visual C, SQL, Unix, MathCAD, MATLab, Maple V, Remcom (finite element analysis and simulations for RF coil design) and Interactive Data Language (IDL), RF coil development, Biological System Modeling, Experience with Radiological modalities (MRI, CT, Nuclear Medicine, and Angiography, Positron Emissions Technology).
Skills : Microsoft Office, Prolaw, NetDocs, Amicus Attorney.
- Supported export business and mitigate regulatory concerns for product categories.
- Included personal care, home care, OTC (over-the-counter) drugs, pesticide and food products.
- Helped research and/or stay abreast on latest global initiatives and how they impact Watkins' strategic objectives.
- Identified and managed third party consultants as needed to drive new product launches and/or new international markets within department budget.
- Researched complex cross-cultural, cross-regulatory issues and simplify them into ease of strategic goals to guide Watkins to jump through regulatory hurdles.
- Lead product label review initiatives to ensure compliance with current regulations for where the products are sold.
- Ensured marketing approval of b. Braun's device products in us and in other foreign countries.
Regulatory Affairs Manager II Resume
Summary : Extremely organized legal assistant/paralegal that manages multiple caseloads and sorts and categorizes vast amounts of legal documents and data with ease. Applies excellent writing skills in drafting briefs, legal memorandums, motions and correspondence. Works independently with little guidance from supervisors.
Skills : Inventory Management, Microsoft Office, Staff Training.
- Ensured company complies with all required federal, state and local regulations.
- Included managing all required reporting and submissions to each relevant government agency.
- Managed the regulatory staff to ensure the business maintains regulatory compliance and supports the company's product stewardship goals.
- Responsible for maintaining existing registration and preparing new product submissions, amendments and notifications to the U.S.
- Anticipated and identified the business's regulatory requirements and needs, to develop innovative strategies and solutions to meet the company's business objectives and gain competitiveness within the marketplace.
- Negotiated with state and federal regulatory authorities to define and develop regulations impacting company interests and operations.
- Communicated new regulatory policies and/or regulations throughout the organization and within each of the businesses to ensure the company's freedom to deliver its products on time into the marketplace.
BS In Environmental Health
Regulatory Affairs Manager III Resume
Summary : Established expert in Regulatory Affairs and Quality Assurance in the area of Medical Devices. Proven track record of gaining regulatory approval for new medical devices. Special emphasis on Electro-mechanical software driven devices and In-Vitro Diagnostic Devices. Drive new product development in cross-functional teams, developing complex regulatory strategies.
Skills : Excel Modeling, Databases, Financial Modeling.
- Signed contracts and approvals for drugs with the Food and Drug Administration (FDA) on daily bases.
- Communicated with government officials in order to update system data base on upcoming drugs and approvals.
- Prepared pharmaceutical and financial reports.
- Reviewed the combination product used to provide Duo-Dopa pharmaceutical through parenteral infusion.
- Reconstructed device Technical Files on site.
- Finalized facility permitting with NYSDEC including hazardous waste (RCRA) storage permit, air permits.
Regulatory Affairs Manager/Assistant Resume
Summary : Regulatory Affairs Manager at the biotech company Lentx, inc. focusing on the discovery, evaluation and development of small molecule therapeutics and genetic delivery platforms. Eight years of experience in life sciences research and drug development program management including; target identification, high throughput screening and pre-clinical studies.
Skills : QMS, PEACH TREE, AS400, LOTUS NOTES, MICROSOFT WORD.
- Organized, planned, assessed, and managed pharmaceutical regulatory affairs and quality assurance according to FDA rules and regulations pertaining to good laboratory (GLP).
- Reviewed and determination of the appropriate indication in order to increase the likelihood of FDA approval of a potential drug, biologic or medical device including; patient benefit, surrogate endpoints, precedents, FDA panels and protocols.
- Prepared and reviewed drug developability assessments including; pharmacology, metabolism, delivery, toxicology, pharmacokinetics and chemistry.
- Prepared, evaluated and presented of text and tabular expositions in order to facilitate the regulatory review of the common technical document (eCTD) including; tone, correctness, conciseness, clarity and consistency.
- Prepared, reviewed and submission of investigational new drug applications (IND) according to (21 CFR) and new drug applications (NDA) in accordance with the US Food Drug and Cosmetic Act and International Commission of Harmonization (ICH) in eCTD format.
- Prepared, reviewed and submission of biological license applications (BLA) to the Center for Biological Evaluation and Research (CBER).
- Included HIPAA considerations, trial objectives, design, blinding techniques, procedures, accountability, risks, confidentiality and case report forms (CRFs).
Ph.D. In BIOSCIENCES
Associate Regulatory Affairs Manager Resume
Headline : Energetic MBA with chemical engineering background. Expert in medical device regulatory compliance and project management. Excellent in communication abilities and leadership techniques. Wide range of experiences in dealing with complex issues in supply chain, product development and regulatory compliance.
Skills : Health Canada, Medical Device Regulations, Project Management, Cross-Functional Team Leadership.
- Insured products are up to par when it comes to local and global regulations.
- Applied knowledge of REACH, GMO, BSE/TSE, Toxicology Reports, Nagoya Protocol, CITES.
- Prepared Safety Data Sheets to meet .
- Researched and reviewed actual and proposed changes in state and federal statutes and regulations Mange all state filings including annual reports, .
- Managed the business units regulatory affairs program including electrical safety, laser safety and electromagnetic compatibility for global product .
- Managed third party testing laboratory evaluations including UL, TUV and CSA Laser Safety Officer.
- Created and submited FDA-CDRH reports, implement.
Assistant Regulatory Affairs Manager I Resume
Objective : Implant Medical Device Testing: 5 years' of hands-on experience with implant medical devices testing methods per ISO, BS, GB & YY standards, bench tests as well as preclinical studies. Biocompatibility Testing for biomaterials and medical devices  Quality Control: Experience with  and 21 CFR Part 820 on manufacturing process, and finished product inspection.
Skills : Good negotiating skills, Judgment skills and presentation skills.
- Responsible for assessment of device changes for regulatory implications.
- Acquired and maintained current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic.
- Disciplined as relevant to assigned projects.
- Interfaced with regulatory authorities on regulatory and technical matters.
- Managed the creation and review of Standard Operating Procedures.
- Provided regulatory support on project teams and assisted with Quality efforts.
- Provided regulatory guidance for premarket submissions and complex submissions issues.
Masters Of Science
Regulatory Affairs Manager Resume
Summary : Coordinated, organized, and ready to improve company visibility and efficiency. Brainstormed with management staff to develop more appropriate marketing ideas. Well interacted with diverse groups. Negotiation and Collaboration Decision-Making and Follow-Through Planning and Organizational Skills Communication and Confidentiality Reliability and Flexibility Proficient in Arabic, English.
Skills : MS Office, Excel, Ms Word.
- Consolidated all operations in Ft. Lauderdale, FL.
- Specialized in handheld glucose meters and test strips REGULATORY AFFAIRS MANAGER Collaborated to create one company-wide quality system by merging two separate systems.
- Provided regulatory management, project management, and designed and documentation controls.
- Compiled CPP applications and review new CPP certificate and submit them to the Health Authorities.
- Projected managing multiple requests simultaneously to ensure Performance Metrics and filing deadlines are reached.
- Contacted with the Client team for project discussions.
- Obtained documents required to be included in the CPP request.
BS In Mechanical Engineering