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Regulatory Affairs Manager

Company: Oasis
Location: Glendora
Posted on: November 22, 2021

Job Description:

Job Summary
The Regulatory Affairs Manager is responsible for regulatory compliance, product registration, labeling, and advertising compliance for the Company both internationally and domestically. The position performs a vital part in enhancing the company's infrastructure, and has the capability to contribute to the strength and sustainable growth of Oasis Medical
Essential Job Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Formulate and lead regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
Ensure compliance of all processes and procedures to applicable standards and regulations
Act as Person Responsible for Regulatory Compliance (PRRC) to meet the EU MDR 2017/745 requirements and other regulatory bodies requirements:
The device conforms to the manufacturers quality management system prior to release
The technical documentation and EU declaration of conformity are properly maintained
The post-market surveillance obligations are complied
The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices
Communicate with regulatory agencies, notified bodies, and competent authorities
Communicate proactively within the company on regulatory strategies, key issues and any other critical topics throughout the life cycle
Provide regulatory inputs on cross-functional project teams to achieve compliance and meet business objectives
Assist in the identification of relevant guidance documents, international standards, or consensus standards and notify top management
Identify, assist, and prepare regulatory submissions for approval that include, but are not limited to the following :
US FDA 510 (k) Premarket Notifications
US FDA Drug Master Files and annual updates
Technical Documentations (Files) for EU
Substantial/significant changes and new product submissions
Renewal of Technical Documentations (Files)
Support internal and external Quality System audits by regulatory agencies and customers
Oversee, manage, and assist with the following activities:
Technical Documentation (File) audit responses and resubmissions
Change assessment to product design, specifications, and processes
New product design control and release
Product recalls
Field Safety Corrective Actions and Field Safety Notices (EU)
Adverse event/Vigilance reporting
Writing and/or revising regulatory related operating procedures and documents
Maintain applicable Establishment Registrations, Drug and Device Listings, State (domestic) and International Licenses
Review and provide regulatory approvals for the following, but not limited to: product labeling, marketing materials, quality documents (operational procedures, work instructions, validation study protocols and reports, etc.), non-conformances, CAPAs, Risk Management Documents, Clinical Evaluation Reports (CERs), and Post-Market Surveillance (PMS) related plans and reports
Review and assist with customer complaint reportability assessment
Identify change and improvement in work processes to promote efficiency within organization
Adhere to general safety rules, manufacturing procedures, quality procedures as applicable, and company policies
Exhibit professional behavior and demeanor at all times; proactively resolve issues using Best Practices
Perform other duties and responsibilities as requested or assigned
Experience/Training/Education
MS in Regulatory Affairs, Regulatory Science, or a related technical field preferred.
Minimum 10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of pharmaceutical products and sterile, disposable medical devices.
Thorough understanding of FDA QSR (21 CRF 820), medical device manufacturing principles, relevant ISO/EC standards, CFRs, MDD 93/42/EEC, MDR 2017/745, CMDR, and ISO 13485 requirements.
Thorough understanding of the CFRs, FDA/ICH guidelines and cGMP's, as they pertain to pharmaceuticals.
Knowledge of pharmaceutical industry regulatory affairs throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
Knowledge/Skills/Abilities
Knowledge of pharmaceutical industry regulatory affairs throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
Capability to respond to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
Ability to interpret Regulatory Authority policies, provide guidance and correctly apply them as appropriate in product development.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
Ability to review detailed scientific information and assess whether technical justifications are presented clearly, and conclusions are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Has a desire to function as a team member by listening, asking questions, collaborating, and contributing on daily basis
Organized and able to perform in a time-sensitive environment
Comfortable with prioritizing and managing multiple assignments
Demonstrate a flexible and collaborative approach with various cross-functional teams
Able to draw on diplomatic communication skills

Keywords: Oasis, Glendora , Regulatory Affairs Manager, Executive , Glendora, California

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