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Job Title: Regulatory Affairs Associate (direct hire)

Location: Trumbull, CT

Position Summary:

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.

Key Functions:

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.

Qualifications:

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.

Lighthouse Professional Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, color, Religion, gender, disability, veteran status, sexual orientation, gender identity, national origin or other protected classification.