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Job Title: Regulatory Affairs Associate (direct hire)
Location: Trumbull, CT
The Regulatory Affairs Associate will provide the internal regulatory affairs support for post-marketing of Class I , II and III medical devices. The incumbent will support the registrations and technical files projects for existing and acquired product lines. At the direction of the Sr. Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations.
- Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations.
- Identifies, completes, and files all necessary documentation as required for site registrations both domestic and international locations.
- Assembles, Reviews and updates "Technical Files" for existing and acquired products.
- Prepares and updates "Declarations of Conformity" as per MDD.
- Processes and updates CFGs.
- Supports International Standards Organization implementation and maintenance.
- Reviews Medical Device Regulatory standards and updates to ensure compliance.
- Notifies Supervision and Management of Product safety issues.
- Assists with maintaining and updating Order Entry Restrictions database.
- Provides liaison with FDA, Notified Body, and Authorized European Reps.
- Maintains collaborative relationship with R & D, Marketing and Operations is required.
- Maintains collaborative relationships with external partners including regulators and external OEM suppliers.
- Performs additional duties as required by management.
- Bachelor's Degree in Sciences, Engineering, Technical or equivalent.
- Minimum 3-5 years quality, regulatory, compliance manufacturing, operations and/or engineering is required
- Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations.
- Three - Five years QA/RA experience in the medical device or related industry.
- Strong communication and problem solving skills.
- Advanced computer skills.
- Project organizational skills.