Sr. Specialist, Regulatory Affairs

  • Anywhere

Company :
Hollister Incorporated

Location :
Libertyville, Illinois

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
We Make Life More Rewarding and Dignified Location: Libertyville Department: Regulatory Summary: The Senior Regulatory Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion. Responsibilities: – Lead or represent Regulatory Affairs in project teams – Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements – Prepare, review, and approve department SOP’s. – Provide regulatory advice to project teams. – Respond to regulatory authorities’ queries within defined deadlines – Maintain regulatory files in a format consistent with requirements and stored in defined electronic system – Develop and initiate complex regulatory project plans – Manage regulatory activities relating to specific portfolio of products/projects (product owner) – May review labeling and promotional material for compliance with local regulations – Maintain annual licenses, registrations and listings with FDA and Health Canada. – Independently investigates and reviews proposed regulations on a federal and state level (domestic and international) that affects the viability of Hollister Business – Independently investigates and review existing and proposed standards (ISO, EN, BSI, etc.) that are applicable to Hollister Business Requirements: – 5 years’ experience in a regulated industry (e.g., medical device, cosmetics, pharmaceutical). Higher education may compensate for years of experience – Would consider Specialist level for individual with under 4 years – Knowledge of UDI and MDR regulations – Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fields is preferred. – Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). – Exercise independent judgment – Strong written and verbal communication skills – Knowledge of regulations and design controls – Developing negotiation skills – Technical system skills (e.g. word processing, spreadsheets, databases, online research) – Ability to manage multiple projects and deadlines – Ability to identify compliance risks and escalate when necessary – Travel 10% Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities. Job Req ID: 28998 Nearest Major Market: Chicago Job Segment: Regulatory Affairs, Law, Compliance, Internet Research, Legal, Research Hollister is an EO employer – M/F/Veteran/Disability