Join Steris as Regulatory Affairs Specialist in Des Plaines Illinois. At the Steris you will perform tasks as listed below, Apply Steris career in Des Plaines IL.
Position : Regulatory Affairs Specialist
Job Category: Regulatory Affairs
Work location : Des Plaines, Illinois
Job Segment : Medical, Engineer, Developer, Product Development, Healthcare, Engineering, Technology, Research
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.
The Regulatory Affairs Specialist will ensure medical device regulatory requirements are met for marketing of Hu-Friedy products in local and strategic international markets Further, this role provides strong product management leadership for medical device regulatory submissions, registrations, and internal policy and procedures needed for compliance to international standards and regulations. Internally, this position interacts with all functions (e.g. engineering, quality, sales, marketing, procurement and manufacturing) and will work with all levels (e.g. management and support staff). Externally, this position interacts with regulatory agencies, distributors, consultants, customers, partners, and vendors.
1. Manage regulatory files and databases to ensure prompt and accurate access to regulatory information and provide reports to Management concerning current, pending, and future registration activities.*
2. Prepare and assemble documentation for product or facility registrations in local or international markets, as requested.*
3. Develop and recommend strategies for the earliest possible approvals of device applications.*
4. Assess the impact of documentation delays, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.*
5. Interpret Regulatory Agency requests and correctly apply them as appropriate for assigned devices.*
6. Research new and/or modified standards, regulations/laws and determine applicability to the organization and/or product.
7. Ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements.*
8. Work effectively with cross-functional staff across multiple sites as well as global external partners.
9. Contribute to preparing for external audits. Monitor/track open non-conformances/observations from internal and external audits as assigned.
10. Review change requests for packaging, literature, work instructions/procedures, production BOM/routers, and other controlled documents for regulatory compliance.*
11. Represent the regulatory function for new product development projects, as assigned.
12. Provide support during facility inspections by external parties (FDA, ISO, MDSAP, etc…)
13. Delegate tasks and assist in training other document control or regulatory staff within the department, as needed.
14. Participate in other activities as needed, e.g. post-market surveillance, training, export documentation, etc..
15. Participate in professional associations, industry/ trade groups (local/regional/international), and appropriate
16. Ensure documents are certified and legalized or notarized, as required.
Functional Knowledge, Skills, and Abilities
1. Minimum of 3 to 5 years of relevant regulatory experience in the medical device industry with increasing scope of responsibility.
2. BA/BS degree in life sciences, engineering or related field.
3. Multilingual is a plus, Spanish highly preferred.
4. RAC accreditation (through RAPS) is a plus.
5. Must be proficient with Microsoft Word, Excel, Project and SharePoint.
6. Experience working with ISO 13485 regulatory and quality system principles and practices.
7. Experience and knowledge with domestic and international laws, regulations, and guidance that affect medical devices.
8. The ability to independently research, learn and manage implementation of regulatory requirements for additional international markets.
9. The ability to write and edit technical product documentation.
10. The ability to apply risk-benefit analysis techniques.
11. Strong project management skills and experience.
12. Translate and communicate technical regulatory issues for nontechnical audiences.
13. Ability to raise issues with colleagues and managers in a proactive, professional manner and drive win-win outcomes.
14. The ability to participate in training as a trainer or trainee either on or off site.
15. The ability to travel up to 10% of working days is required.
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: Chicago
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