Senior Regulatory Affairs Specialist

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 Specialist for a 12 month FTC - maternity leave.

WHAT YOU WILL DO

Reporting to the Lead, Regulatory Affairs (RA) Specialist within the RA Department, the successful candidate will be responsible for supporting the development and implementation of STERIS’s regulatory strategies for biocidal and detergent product lines within the EMEA region. This includes preparing and submitting international regulatory dossiers to obtain and maintain product approvals under applicable frameworks such as EU Biocidal Products Regulation (BPR), REACh, national biocide legislation and compliance activities pertaining to chemical products and detergents.

The successful candidate will also provide support for plans to achieve identified corporate regulatory policy objectives. They will be responsible for keeping abreast of and providing regular reporting to business stakeholders on key regulatory developments that impact products, customers, or STERIS’s business directly.

Duties - cont'd

• Identify regulatory requirements for new products or product enhancements early in the product development cycle.
• Collate information and documentation to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims.
• Review product revision requests to assure compliance with regulatory requirements in the EMEA region.
• Supporting with the management of existing product registrations in line with business objectives to ensure supply continuity.
• Work within project teams to support development of regulatory strategies for new and existing product developments.
• Work with and build relationships with key stakeholders and regulatory consultants to ensure registration objectives are met.
• Review and approve labelling and marketing literature.
• Work with direct Supervisor and senior internal stakeholders to identify key initiatives, and upcoming regulatory developments that may impact products, customers and the business.
• Provide input to SDS creation and amendments.
• Provide regulatory support for compliance REACH

Required Experience

• Provide regulatory support for compliance REACh
• Minimum of 2 years of direct regulatory experience
• Minimum of 1 year working with biocidal products under EU BPR, preferably PT2.
• Understanding and experience working with the following regulations: CLP, REACh, detergents and the UK equivalents.

Preferred Experience

• Excellent attention to detail – ability to review complex regulatory documents and product labelling with precision and accuracy.
• Time management – ability to manage own workload according to internal, external and legislative deadlines.
• Ability to interact effectively with business partners and business functions such as marketing, R&D, sales and quality.
• Good communication, and interpersonal skills to be able to liaise with regulatory authorities, internal stakeholder and external consultants.
• A pro-active approach to problem solving.
• Knowledge of impact assessments and change management processes.
• Comfortable working across a multi-country, multi-regulatory environment

• Familiarity of working with IUCLID, R4BP3, REACh-IT

Skills