Job Title: Senior Regulatory Affairs & Quality Compliance Specialist

Req ID: 35653

Job Category: Regulatory Affairs

Derby, UKM, GB, DE21 6LY

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 Senior Regulatory Affairs and Quality Compliance Specialist to support our Regulatory function

WHAT IS INVOLVED

Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions.

Provide support to Quality & Regulatory Compliance management in the development, enhancement, standardization, execution, and implementation of processes to manage the notified body audit program. Support includes coordination of facility audit scheduling and issue resolution.

Responsible for monitoring the Regulatory Compliance email inbox and incoming mail for new events and MDR correspondence from FDA, preparing the agenda and assembling the documentation of potential reportable events for review by the Reportable Events Committee; submitting electronic MDR reports to FDA.

Participate in quality system audits at global facilities as requested.

Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.

At the direction of Quality & Regulatory Compliance management, support FDA and other regulatory agency responses following receipt of formal observations.

Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.

Develop, analyze, and maintain trend reporting for facility QMS data to heighten awareness and drive action for relevant leadership.

Completes assigned document control activities for STERIS Quality Management System policies, procedures, and work instructions, including the review and approval of associated promotional material, following STERIS document control processes and communicates and posts approved documents.

Review, analyze and action new and revised regulatory standards as an input into the QMS including Management Review, technical documentation and/or design history files (where applicable).

Gathers information and documentation on proposed, newly acquired, modified products and/or processed products to assist in product classification, submission, and approval to support continued, compliance business.

Supports STERIS Regulatory management’s identified strategy and accurately communicates it to business partners throughout assigned projects and processes. Engages Regulatory management as necessary when changes occur, or new risks or requirements are identified.

Generating and maintaining technical documentation and/or design history files.

Applies regulatory knowledge and judgment to identify potential compliance concerns and gathers and presents sufficient information to facilitate Regulatory management’s appraisal of any proposed changes or resolution of compliance issues.

Monitors current projects and pending and planned submissions to track timelines, identifies any unexpected delays, and communicates progress on projects and submissions to business partners.

EXPERIENCE REQUIREMENTS

Minimum of two (2) years professional experience
Bachelor’s Degree
21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
21 CFR Part 803 – Medical Device Reporting
21 CFR Part 806 – Medical Device Corrections and Removals
21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls
21 CFR Part 11 – Electronic Records, Electronic Signatures
ISO 13485 Medical devices – Quality management systems
ISO 9001 Quality management systems – Requirements
ISO 14971 Application of Risk Management to Medical Devices
EU Medical Device Directive 93/42/EEC
EU Medical Device Regulation 2017/745
EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System
UK Medical Devices Regulations 2002

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.