Job Title: Manager, Regulatory Affairs
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Regulatory Affairs Manager is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
Provide guidance on regulatory standards and strategies for compliance
Supports the development and implementation of regulatory strategies throughout the product lifecycle including product development, labeling and promotional materials, and regulatory evaluation of changes.
Prepare, or manage preparation of, regulatory submissions and registrations required for FDA, Canadian, EU and other international markets of new or modified Class II (510(k)) or Class III (PMA supplements) medical devices.
Interface with the FDA and international health authorities as required.
Manage regulatory projects
Job Family Summary
Regulatory Affairs Manager (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
What is expected of you for success in your role
Demonstrates advanced knowledge of healthcare-related regulations
Demonstrates broad knowledge of development process for select product lines
Demonstrates understanding of expertise for PMA or NDA submissions
Applies relevant regulations and statutes to further product submissions of medium to high complexity
Interfaces with other functions/departments to assess applicability of proposed claims and labeling submissions
Contributes to executive policy and strategy and develops and implements Quality management strategy and plans, including resources, systems, timescales and financial's, in order to support, contribute to, and integrate within, the Company's annual business plan and long term strategy
Reviews, communicates and provides appropriate support to ensures the management and maintenance of all Quality accreditations and Medical Device regulations, principally the Medical Devices Directive 93/42/EEC, IS0 13485, 21 CFR 820, CMDCAS, JGMP
Prepare, submits and maintains all product pre-market RA activities including FDA 51O(k), CMDCAS licenses & other global registration files
Manages Design Reviews and verifications during product development and to create, document and execute appropriate validation plans and product release to comply with applicable standards
Assists and supports distributors and customers with any Product Registration required by foreign Health Authorities to meet international Medical Device regulations
Supervision and direction of CSV (computer system validation / conformity assessment) according to valid laws, directives, guidelines and SOPs
Supervision of Validation team in matters of resource planning and fulfillment of project timelines
To monitor, inform, communicate and apply RA standards created by external bodies, and integrate them within the QMS
To review all new product submissions, internal change requests and all product labeling, IFUs and user manuals for regulatory compliance
Execution and documentation of supplier and internal audits
Scientific, medical or technical education / graduate or university degree or equivalent
Bachelor's degree strongly recommended
Minimum 6 years in an accredited Quality Management Role
Minimum 5 years general business background with specific knowledge of medical devices and their regulations (laws, directives, standards, and guidelines)
Minimum 3 years in Risk Management and improvement techniques
A proven ability to train others and to promote good practice
Proven analytical ability to problem-solve quality, commercial, resourcing and customer issues (Lean Six Sigma)
Ability to build, develop and maintain internal and external customer relationships
Ability to work under pressure and to tight deadlines
Ability to cope flexibly with new situations