Regulatory Affairs Specialist (Must Have Medical Device Regulations)

Title: Regulatory Affairs Specialist (Must Have Medical Device Regulations)

Location: Franklin Lakes, NJ

Duration: 6+ Months

Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Job Category: Regulatory Affairs / Compliance

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Description:

This position is responsible for leading regulatory submissions required to market medical devices in the U.S./Europe (and other international markets if needed such as China/Russia) and regulatory affairs activities associated with sustaining marketed devices for the BD Integrated Diagnostics Solutions - Specimen Management business group including blood specimen collection needle/setss and blood collection tubes. This role requires the analysis of data, problem solving and evaluations of various factors.

Responsibilities:
1. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal Letter to File (U.S.) for changes that do not require a 510(k) submission, and assess also for EU impact.
2. Support preparations of technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
3. Support notifications to the Notified Body about significant changes to CE marked products in a timely manner.
4. Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
5. Represent RA in product life cycle development and/or new product development teams by reviewing, approving, and completing requirements.
6. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
7. Support International Registrations as it relates to product changes and/or new product launches.
8. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
9. Create and maintain regualtory performance metrics.
10. Identify opportunities to improve the existing process and implement the improvements.
11. Work with Regulatory Supervisor to execute large scale projects.
Carry out the above tasks with limited supervision.

Education:

B.S. degree or higher in a life science or technical discipline, preferably in biology, or chemistry, engineering, bioengineering and regulatory affairs. Licenses/Certifications: RAPS Certification is a plus
Experience:
1. Minimum of 5 years regulatory affairs experience in medical device regulations, or 3 years of experience with an advanced degree.
2. Understanding of US, EU and international medical device and IVD regulatory requirements.

Special Skills:
1. Proficient in using various computer/Microsoft Office programs.
2. Strong oral and written communication skills.
3. Project management skills.
4. Handle multiple tasks and prioritization skills.
5. Strong attention to details.