Regulatory Affairs Consultant

24 Apr, 2022

Jobs

Regulatory Affairs Consultant

Roche Laboratories
Indianapolis, IN

Job Summary

Responsible for regulatory submissions strategy for new and modified products under applicable agencies.  Ensures rapid and timely approval on new medical devices and continued approved or cleared status of marketed medical devices. Coordinates the efforts of the business areas in developing information to be included in regulatory submissions based on the developed strategy.  Prepares and submits premarket submissions to FDA and other governmental agencies. Facilitates proposed regulations and advises on impact of such regulations on the company. Interacts with regulatory agency personnel in order to expedite approval or clearance of pending registration and answers any questions.  Represents the company in dealing with agencies and trade associations. May determine methods and procedures on new projects and may provide guidance to other lower-level staff.

A seasoned professional with wide-ranging experience.  Deals with diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

What you do

  • Leads the development of premarket submissions strategies for complex regulatory projects; serves as primary interface to FDA.
  • Develops standardized policies/procedures and reviews/approves regulatory deliverables in the DCC process.
  • Reviews, interprets, and reports on product specific regulatory issues that may have material impact; assists in developing strategic and tactical responses to influence a reasonable regulatory environment; serves as an interface to local and national trade associations and federal officials.
  • Provides consultative and training support related to premarket submissions and product labeling

Who you are

  • Bachelor’s degree in Chemistry, Biology, Biochemistry or other related field
  • 3 years of experience working in an FDA-regulated industry
  • Working knowledge of current FDA or state, federal, or clinical laboratory regulations or consensuses.

Preferred

  • 5 years of experience working in the in vitro diagnostic products field
  • Notary Public certification
  • Familiarity with Windchill
  • Working knowledge of Good Promotional Practices

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company’s health and safety obligations and/or applicable law or guidelines.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Job posted: 2022-04-24