Regulatory Affairs Associate

Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Accounting & Finance and Clerical.

Lighthouse Professional Services is committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.

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.