24 days old

Regulatory Affairs Specialist

Kelly Services
Miami, FL 33126
Kelly Services Outsourcing & Consulting Group is seeking a Regulatory Affairs Specialist with IVDR experience for an open-ended assignment with benefits in Miami, FL. The Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR).

As a regulatory process expert supporting the IVDR teams, the RA Specialist:

+ Implements regulatory strategies for IVDR activities

+ Provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices

+ Collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.

+ Works with Program Managers and technical staff to determine action items and deliverables to address gaps in Quality Systems and product documentation.

+ Assists in the creation and revision of procedures, forms, and templates to ensure compliance with the IVDR.

+ Writes technical files as per IVDR requirements and manages the review and approvals of such documents.

+ Tracks and reports status of regulatory deliverables to Program Managers and leadership.

+ Secures necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market companys products in that geography; ensures company complies with the local regulatory requirements of the country in which the product is marketed; prepares the necessary documentation and secures necessary approvals.

+ Responds to regulatory agency inquiries.

+ Applies and/or writes the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity. Manage legalization, Apostille, and notarization process.


+ Bachelors degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering

+ 2-4 years of related experience.

+ Demonstrated experience working with IVDR.

+ Excellent organizational skills and attention to detail.

+ Strong work ethic with an ability to work independently.

+ Possess an ability to read, understand, and summarize technical and scientific information.

+ Ability to interpret and apply regulations to company policies and procedures.

+ Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling.

+ Pragmatic with strong problem-solving skills.

+ Experience working with cross-functional product development teams to ensure regulatory compliance.

+ Medical Device experience.

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

**This position comes with enhanced benefits which include:**

+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid sick days and vacation days*

**Perks of being a Kelly employee:**

+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee

*benefits to be received upon meeting eligibility requirements

**Why Kelly** **** **?**

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at
Posted: 2019-12-25 Expires: 2020-01-25

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Regulatory Affairs Specialist

Kelly Services
Miami, FL 33126

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