Regulatory Affairs Specialist
Company: Disability Solutions
Location: Libertyville
Posted on: March 20, 2023
Job Description:
We Make Life More Rewarding and Dignified Location: Libertyville
Department: Regulatory Summary: The 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. Hollister
Incorporated operates in a hybrid work environment.
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
- Bachelor's degree (or equivalent); 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 #LI-Hybrid Our Total Rewards package in aggregate is
above market and includes competitive pay, generous paid time off
programs, peer-to-peer recognition, health and life insurance,
wellness programs and incentives, generous retirement savings, and
a unique Benefit of Employee Share Ownership Program (BESOP).
Hollister Incorporated is an independent, employee-owned company
that develops,manufactures, and markets healthcare products
worldwide. The company develops and manufactures products for
ostomy care, continence care and critical care, and also develops
educational support materials for patients and healthcare
professionals. Headquartered in Libertyville, Illinois, it has
manufacturing and distribution centers on three continents and
sells in nearly 80 countries. Hollister is a wholly owned
subsidiary of The Firm of John Dickinson Schneider Inc (JDS Inc), a
100 year old company. Hollister is guided by the shared Mission of
JDS Inc, to make life more rewarding and dignified for people who
use its products and services. www.Hollister.com Hollister is an EO
employer - M/F/Veteran/Disability Job Req ID: 31301
Keywords: Disability Solutions, Chicago , Regulatory Affairs Specialist, Other , Libertyville, Illinois
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