Trumbull, United States
6 months ago
For almost 50 years, 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, Finance, Clerical and Light Industrial.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Senior Regulatory Affairs Specialist in Trumbull, CT.
Position Summary and Special Duties:
As a (an) Senior Regulatory Affairs Specialist your day to day duties will consist of and may not be limited to:
The Sr. Regulatory Affairs Specialist will provide the internal regulatory affairs support for post-marketing of Class I, II and III medical devices and in vitro diagnostic products. 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, the Sr. Regulatory Affairs Specialist 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.
- Support preparations of technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
- Works with cross functional teams to deliver supporting documents necessary for Technical Document submissions or Technical File maintenance.
- Support notifications to the Notified Body about significant changes to CE marked products in a timely manner.
- The ideal candidate will have medical device (required) and in vitro diagnostic (preferred) experience in the US and EU.
- Prepares and updates “Declarations of Conformity” as per EU MDD and EU MDR.
- 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 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.
- 3-5 years QA/RA experience in the medical device or related industry.
- Strong communication and problem-solving skills.
- Advanced computer skills.
- Project organizational skills.
- Passing of background check, which may include verification of prior employment, criminal conviction history, educational and driving records.
Duration: Direct hire
Location: Trumbull, CT. or remote.
Salary: depending on experience
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.