Regulatory Affairs Specialist, Cosmetics - Cary, United States - Stryker Corporation

Stryker Corporation

Verified Company

Cary, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Why RA/QA at Stryker?:

We are currently seeking a
Regulatory Affairs Specialist to join our
Medical Division. This is a hybrid role based in Cary, IL.

Who we want
-
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
-
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
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Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

What you will do
As the
Regulatory Affairs Specialist, you will provide information used to evaluate proposed products for regulatory classification and jurisdiction.

You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities.

Provide regulatory guidance to other departments for planned changes.
Provide a critical detailed review of technical documentation prior to FDA submission.
Communicate with regulatory agencies regarding presubmission strategies/regulatory pathway development, submissions, and followup on submissions in review.
Serve as partner to marketing, engineering, clinical and quality on project and product development teams.
Improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.

What you need

A minimum of a Bachelor's Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
Experience in an FDA or regulated industry required, preferably with cosmetics.
02 years in a Regulatory Affairs role
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Experience authoring regulatory submissions for product approval preferred.
Experience interacting with regulatory agencies preferred.
Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
Ability to analyze and resolve nonroutine regulatory issues using independent judgment.
Excellent analytical and writing skills.
Excellent interpersonal, written and oral communication skills.
Effective organizational skills.
Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

About Stryker:

Our benefits:

12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and shortterm disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker

Know someone at Stryker?
Stryker is driven to work together with our customers to make healthcare better.

Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.