Regulatory Affairs Specialist
Proclinical is currently recruiting for a Regulatory Affairs Specialist with our client located in Cincinnati, OH. Successful candidate will provide independent regulatory guidance to cross-functional teams in strategic planning, pre-marketing, and related submissions to support modified product launches.
- Ensures compliance with regulatory agency regulations and interpretations.
- 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.
- 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).
- Demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Consult with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.
- Provide 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.
Skills and Requirements:
- Bachelor's degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration.
- Must have at least 2-4 years of Regulatory Affairs experience in the medical device industry.
- Must have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all projects maintain compliance to worldwide regulatory requirements.
- Must have previous experience with document management systems and change control systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.