Sterilmed, a member of Johnson & Johnson's Family of Companies is recruiting for a Regulatory Affairs Specialist III for the Central Region.
As an FDA-registered medical device manufacturer, we provide an affordable solution for hospitals faced with the challenge of reducing costs without compromising patient care. We are proud to be a part of keeping healthcare accessible and affordable for all by delivering deep, sustained savings for our reprocessing customers.
The Regulatory Affairs Specialist III 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. Under 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 RA Specialist III 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.
· 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.
· Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
· Provides solutions to a variety of problems of moderate scope and complexity.
· Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
· Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
· Provides regulatory guidance to product development teams and responds to product information requests
· Provide Regulatory Affairs support during internal and external audits
· Assists in the development of best practices for Regulatory Affairs processes
· Represents Regulatory Affairs on cross-functional project teams
· Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies).
· Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
· Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.
· Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
· Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
· Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
· Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
· Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances
· Bachelor degree from accredited college or university in science, biomedical engineering, Medical / scientific writing, public health administration
· 4+ years of regulatory affairs or related and/or equivalent experience
· RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society (desired)