Johnson & Johnson Careers
Senior Regulatory Affairs Program Lead--Biosurgery
Requisition ID: 7832180724
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead--Biosurgery located in Somerville, NJ with a minimum of 10% domestic and international travel.
Johnson & Johnson Medical Devices is currently $20 billion in worldwide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Senior Regulatory Affairs Specialist provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. With minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Specialist helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the development of best practices for Regulatory Affairs processes.
POSITION DUTIES & RESPONSIBILITIES:
- Lead or supporting Regulatory Team member supporting continued access of new/modified/current Biosurgery products in key regions
- Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and approvals
- Reviews various changes made to existing products to assess the impact on safety and effectiveness;
- Provides guidance to project team members regarding regulatory compliance issues.
- Partners with EU, Regional, Policy, RALI leaders to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's portfolio of products and help drive strategies to achieve a competitive advantage and benefit for the patients.
- Works with team members and commercial partners to oversee the regulatory aspects of new products launches, and the assessment of the impact product changes have on the status of regulatory licenses.
- Influence and negotiate with or without direct authority in order to build and enhance external partnerships.
- Works to understand the expectations, future needs, and motivations of external and internal stakeholders
- Ensures compliance with regulatory agency regulations and interpretations.
- Establish and prepare appropriate regulatory filings for product approvals, and effectively communicate submission timelines and risks to cross-functional teams
- Communicates and consults as needed with management on regulatory submission timelines and strategies
- Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (for example, represents Regulatory in the product recall and recall communication process).
- Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives.
- Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).
- Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
- Possesses excellent written and verbal communication skills
- Experience in preparation of US Regulatory files as well as European Technical Files and/or Design Dossiers is preferred
- A Bachelor’s Degree from an accredited college or university is required. A degree in science, biomedical engineering, medical/scientific writing, public health administration is preferred. An Advanced Degree (e.g. M.S., PhD, etc.) is preferred.
- Must have 6+ years’ of business experience and 4 years working in Regulatory Affairs.
- Experience in medical device regulatory affairs is required. Additional experience in biologics and/or combination products is preferred.
- Must have successful track record of supporting project teams and preparing submissions for Class II and Class III medical devices.
- Solid Knowledge of US and European regulatory processes for Class II and Class III devices is required.
- Must have excellent written, verbal communication and presentation skills.
- Must be able to communicate clearly, succinctly and effectively over the phone and in writing.
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Somerville
Ethicon Inc. (6045)