Regulatory Affairs Specialist in Mentor OH

Full-time @Steris in Chemical Research jobs , in Engineering , in Healthcare jobs , in Inspector jobs , in Medical jobs , in Product Development jobs
  • Mentor, OH, US, 44060 View on Map
  • Apply Before : August 18, 2022

Job Description

Join Steris as Regulatory Affairs Specialist in Mentor Ohio. At the Steris you will perform tasks as listed below, Apply Steris career in Mentor OH.

 

Position : Regulatory Affairs Specialist

Job Category: Regulatory Affairs

Work location : Mentor, Ohio

Job Segment : Medical, Chemical Research, Product Development, Inspector, Healthcare, Engineering, Research, Quality

 

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
Reporting to the Director Quality and Regulatory Compliance within the RA Department, the incumbent 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

Support Director Quality and Regulatory Compliance and other Regulatory Affairs staff with all regulatory matters (audit, adverse event, change control).
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.
May work with Director Quality and Regulatory Compliance 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
Required Experience

Government agency and / or legislative experience required.

Preferred Experience

Experience with government relations and regulatory experience 
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.

#LI-SA2
Skills

Ability to interact effectively and credibly at senior levels.
Demonstrated excellence in the following: communication skills, listening skills, interpersonal skills, cross BU team coordination, planning, research, diplomacy, advocacy and sales skills.
Ability to operate in a business devein model providing quick, salient analysis and concrete action plans with emphasis on understanding and anticipating business needs and interests, and devising proactive approaches / responses.

 

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STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. 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: Cleveland

Nearest Secondary Market: Akron

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Required skills