Regulatory Affairs Specialist - Leicester, United Kingdom - STERIS

STERIS
STERIS
Verified Company
Leicester, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.


HOW YOU WILL MAKE A DIFFERENCE:

About you:

Do you want to spend your working time making a difference in the world around you? Are you passionate about Healthcare and Life Sciences? If so, then a career with STERIS in Regulatory Affairs could be a great fit for you.

About Us:

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.


The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS's global business plans.

This includes meeting registration and/or submission requirements in the US and international markets and working with product acquisition or development teams to ensure these requirements are met.

This group also identifies and supports Quality and Regulatory Compliance needs of the Corporation.

We are currently recruiting for a Regulatory Affairs Specialist to support our Regulatory function

This is Hybrid position

May require occasional (10%) local or international travel to STERIS facilities, government agencies, Customers, trade shows or training courses.


WHAT IS INVOLVED:


Registration Activity

  • Maintain submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
  • Monitor approved registrations in respect to expiry and ensure management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
  • Interact with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.
  • Prepares, compiles, and submits regulatory documents for the registration of current and new products in international markets.

Monitoring Registration Requirements within Region

  • Work with incountry representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions
  • Maintains uptodate knowledge of regional and national regulations, guidelines, and advisory documents required for marketing STERIS products in a specified region.
  • Communicate applicable regulatory requirements to STERIS Regulatory Affairs management and business partners.
  • Analyze impact and communicate to management changes in regulations or requirements that have been identified.

International Shipment Hold Report

  • Review the International Regulatory Status Tracking (IRST) report daily to monitor a specified region for activity not yet permitted or approved in a country.
  • Investigate all unapproved activity on report to determine cause, work with RA staff to determine an appropriate strategy for hold release.

General Duties

  • Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to job functions.
  • Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
  • Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
  • Conduct daily activities of assigned job responsibilities and projects as assigned.
  • Support a safe, clean and secure working environment by supporting procedures, rules and regulations.

REQUIRED EXPERIENCE:


  • At least 2 years prior international regulatory experience is highly desired.
  • Selfstarter that is highly organized.
  • Strong interpersonal skills ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
  • Strong oral and written communication skills.

EDUCATION:

Bachelors degree, preferably with scientific, engineering, regulatory, quality systems or legal, core concentration.


STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.

We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD.

STERIS is a $3B, publicly traded (NYSE:
STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.
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