Responsibilities
Lead the preparation of regulatory submission documentation
Work with project teams for New Product Development, Sustaining and cost-saving projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project
Provide regulatory support for internal and external (Regulatory Agency) audits and assist with resolving observations
Manage facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs])
Identify specific changes in global regulations, develop strategies for compliance and provide updates of upcoming changes
Evaluate and implement procedures pertaining to corporate and departmental regulatory activities
Qualifications
Bachelors degree in Science/Technology, Mechanical/Biomedical Engineering, a clinical field or equivalent
3+ years of Regulatory, Clinical or Engineering experience in the food, drug or device industry
Understanding of global medical device requirements and practical experience in implementing or managing such activities
Successful track record working in a global matrix/collaborative environment
Software system familiarity, including Learning Management Systems, Document Management Systems and Microsoft Office Suite
Preferred Qualifications
Oncology experience
Professional certifications such as CQM/OA, RAB or RAPS
This job will be reviewed periodically and is subject to change by management.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Companys facilities.
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