Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead, located in Irvine, CA.
Cardiovascular Specialty Solutions Group (CSS) Group is combining ASP, Acclarent, Biosense Webster and Mentor into a single business unit, single global management board, single P&L.
One geographic Medical Device hub in Irvine will allow for critical mass and geographic efficiencies, including an enhanced ability to attract and develop talent and drive product portfolio to accelerate innovation.
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat.
Advanced Sterilization Products (ASP) truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
This position is specific to Mentor Worldwide, LLC.
The Senior Regulatory Affairs Program Lead will provide administrative and technical support to regulatory affairs management in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. Major responsibilities may include:
- Writes, coordinates, compiles, and submits Regulatory documents to FDA, EU notified bodies, and other Regulatory Agencies, including EPA and International Authorities.
- Also includes the preparation of international documents, including Technical Files and Design Dossiers.
- Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
- Creates detailed Regulatory Plans.
- Includes in-depth team involvement, including Core Team membership for complex projects.
- Evaluates proposed product modifications for Regulatory impact on a world-wide basis.
- Completes Regulatory Assessments as needed.
- Ensures compliance with regulatory agency regulations and interpretations.
- Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Prepares responses to regulatory agencies’ questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Develops timelines for submissions under the direction of senior regulatory affairs staff.
- Provides solutions to extreme complex problems.
- Provides regulatory advice to project teams.
- Other Duties as assigned.
- A minimum of a Bachelor’s Degree is required, an advanced degree is preferred.
- A minimum of 6 years of related professional experience in an FDA regulated industry is required.
- A minimum of 2 years of regulatory affairs experience in the pharmaceutical or medical device industry is required, inclusive of writing, coordinating, compiling, and submitting regulatory documents to the FDA.
- Direct experience with PMA and EU Class III devices is desirable.
- Knowledge of international regulations is preferred.
- Excellent communication skills, both verbal and written is required.
- Must have good organizational skills, analytical thinking, problem solving and investigative skills.
- Proficiency in Microsoft Office and related applications is required.
- This position is located in Irvine, CA and will require up to 10% domestic travel.
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Mentor Worldwide LLC (6177)Job Function