The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for an Regulatory Affairs Specialist II aligned to Biosense Webster located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more about Biosense Webster at www.biosensewebster.com
Responsible for supporting activities that initiate and maintain international product approvals for emerging markets.
POSITION DUTIES & RESPONSIBILITIES:
Partnering closely with other members of the Global Strategy and Dossier Excellence team
· Provides LCM support include a re-registration, renewal, Variations ..etc for w2b & W3 countries.
· Ensures compliance with regulatory agency regulations and interpretations.
· Prepares responses to regulatory agencies' questions and other correspondence.
· Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
· Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
· Provide Regulatory Affairs support during internal and external audits
· Assists in the development of best practices for Regulatory Affairs processes
· Participate on cross-functional project teams to provide RA input.
· USA Establishment registration at FDA and product listing.
· Provide regulatory support to Tender requests from global affiliates.
· Provide countries specific requirements including but not limited to Power of Attorney, Manufacturer's Statement and Declaration Certificate to Affiliates upon request.
· Support LCM requests from Affiliates including technical registration documents, certificates, applications completion, etc..
· Update Declaration of Conformity files as needed;
· Play triage role for MD requisition system of business unit under scope;
· Submit ion of CFG/CFS applications at FDA & health authorities/
· Support in notarization and apostille of different registration documents.
· Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.
· Knowledge of Medical Device regulations are required; international regulations are heavily preferred.
· Excellent communication skills (verbal and written)
· Strong organizational skills are required.
· Project management skills are required.
· Problem solving skills are required.
EDUCATION & EXPERIENCE REQUIREMENTS:
• Minimum of a University/Bachelor’s degree required; within a technical related discipline is preferred.
• Minimum of 2 years of related experience preferably Medical Devices or Pharmaceuticals is required.
• Ability to work both independently and in a team environment is required.
• Ability to problem solve, recognize and find solutions for gaps in processes is required.
• This position is located in Irvine, CA and may require limited travel.