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Regulatory Affairs Specialist

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Company :
Medisafe International

Location :
St. Louis, Missouri

Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT

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Description :
Job Title: Regulatory Affairs Specialist

Req ID: 19353

Job Category: Regulatory Affairs

Country/Region: US

State: MO

City: St. Louis

Zip: 63101

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.

Position Summary

The Regulatory Affairs Specialist is an entry level role that is responsible for supporting the development and administration of STERIS’s global regulatory policy positions across product lines of the STERIS businesses by preparing international regulatory submissions for the full range of STERIS product approvals. The Incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.

Duties

* Identify regulatory requirements for new products or product enhancements early in the product development cycle.
* Gather information 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.
* Work on product teams to develop regulatory strategy based on regulatory submission requirements.
* Review and approve labeling and marketing literature.
* Support Lead Regulatory Affairs Specialist and other Regulatory Affairs staff with all regulatory matters.
* Work with Lead Regulatory Affairs Specialist and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.
* Prepare and / or review written materials for substance and / or policy consistency.

Education Degree
* Bachelor’s Degree in General Studies or Government

Required Experience

* A bachelor’s degree is required
* Post graduate degree (JD or MBA). preferred
* Minimum of 3 years’ previous government relations and regulatory experience.
* Government agency and / or legislative experience required.
* Some understanding of chemical / medical device industry, in particular the workings of the regulatory and legislative environment around the world.
* Comprehension of industry developments and changes in the political environment.

STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.
If you need assistance completing the application process, please call 1 . This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Nearest Major Market: St Louis
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