Regulatory Affairs Specialist Resume Andover, MA - Hire IT People

TECHNICAL SKILLS:

SOFTWARE: Microsoft Office Suite, Microsoft Access, Microsoft Project, Microsoft Visio, Adobe, MasterControl, Sharepoint, eCTDXpress, WordPress, OneDrive

MEDICAL DEVICES: EU MDR, Design Validation, Design Verification, Design Changes, Design Transfer, Device Risk Assessment, MDR, CAPA, QSR, ISO 13485, ISO 14971, IEC 62366

WORK EXPERIENCE:

Regulatory Affairs Specialist

Confidential, Andover, MA

Responsibilities:

Advised internal stakeholders regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Developed and prepared product registration submissions for the US, Canada, EU and select worldwide locations.
Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.
Reviewed and approved labeling, promotional materials, and publications to ensure compliance with EUMDD, EUMDR, FDA and international requirements
Responsible for completing Gap Assessments on Labeling, UDI requirements and Technical Files
Supporting the review of product labeling for medical devices and assisted in maintaining the current labels as required by the new EU MDR.
Revised and Updated the Declaration of Conformity for technical files and dossiers to ensure compliance with the current standards and upcoming requirements as per EU MDR.
Authored new SOPs, work instructions and applicable standards that replaced MDD ERC and EU MDR Declaration of Conformity templates.
Participate in cross - functional team activities by providing support to marketing, R&D and manufacturing teams in regulatory assessment of proposed changes.
Collaborated with country representatives for license registrations, updates and renewals.

Regulatory Affairs Associate

Confidential

Responsibilities:

Drafted a comprehensive Market Access, Regulatory & Re-imbursement strategy to address breast cancer margin in US market
Assessed regulatory pathways for 510(k) submissions to US FDA
Determined an appropriate regulatory timeline for the product entry and marketing
Drafted 510(k) summary, 513(g) request and Laser Product report of the device
Assisted in preparation of technical files and design dossiers for submissions to FDA & EU
Identified issues that may create regulatory obstacles and offered solution to address them

Regulatory Project Associate

Confidential, Boston, MA

Responsibilities:

Assisted the Quality team in maintaining and improving Document Management System
Drafted Training record matrix procedures to ensure compliance with ISO 13485 & 21 CFR820
Evaluated non-conformances and corrective actions for completeness of training modules
Performed audits with the quality team to document or update revisions of procedures
Developed work instructions and SOPs for the document management system of the company
Assisted in regulatory strategies pertaining to labeling and marketing
Identified various procedures for proofreading the labeling documents

Quality & Regulatory Associate

Confidential

Responsibilities:

Assisted with the preparation, and submission of NDA and ANDA to Food and Drug Administration
Compiled modules for eCTD for ANDA submissions
Supported in drafting CMC sections as per regulatory guidelines to comply with CDSCO
Compiled regulatory files for study monitors and auditors to ensure compliance with study specific requirements, policies and procedures and appropriate regulations.
Assisted and worked closely with RA Manager with the update of package inserts, corresponding over labels, redressing & finished product labels, ensure reviews and approvals in a timely manner
Maintained oversight of all required Vigilance regulatory reporting compliance within given timeline
Coordinated development of labeling material with Quality Assurance and Marketing Team
Supported RA Manager to develop, compile & update local SOP on quality management systems, quality accountabilities & working methods.
Communicated with internal and external customers on all quality and compliance-related matters
Provided technical support on QMS-GAP analysis Recall process for a product

Regulatory Project Coordinator

Confidential

Responsibilities:

Proposed and drafted regulatory strategies for product registrations in Brazil, Mexico and Canada
Analyzed potential regulatory hurdles that may affect the entry of product in targeted countries
Determine the potential market size for our product in each of the countries.
Created a timeline (draft) for appropriate regulatory submission in each of the countries.
Identified the most amenable market suitable for the product approval
Communicated with regulatory agencies to confirm the compliance with applicable regulations & standards

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Regulatory Affairs Specialist Resume

Andover, MA

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