15 days old

IVDR Regulatory Affairs Manager

Kelly Services
Miami, FL 33126
Kelly Services Outsourcing & Consulting Group is seeking a Regulatory Affairs Manager with IVDR experience for an open-ended assignment with benefits in Miami, FL. The Regulatory Affairs Manager is a staff-level individual contributor and subject-matter expert who will interpret federal/state/international regulations as they apply to the products, processes and/or procedures, advise on impact of regulations, and devise strategies for compliance.


+ Collaborate with Program Managers and technical staff to determine action items and deliverables.

+ Track and report status of regulatory deliverables to Program Managers and leadership.

+ Liaison with external regulatory agencies.

+ Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.

+ Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market companys products in that geography.

+ Ensure company complies with the local regulatory requirements of the country in which the product is marketed.

+ Prepare the necessary documentation, and secure necessary approvals.

+ Respond to regulatory agency inquiries.

+ Apply and/or write the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.

+ Manage legalization, Apostille, and notarization process.

+ Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.


+ Masters degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 5 years of experience in the offered position or related OR Bachelors degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 5-7 years of experience in the offered position or related.

+ Establishing and implementing premarket regulatory strategy.

+ Writing and submitting premarket submissions to regulatory agencies.

+ Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.

+ Applying 21 CFR 803, 806 and 820 regulations.

+ Communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.

+ FDA audits in multiple roles (regulatory representative, back room lead, scribe, etc.) and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources.

+ 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.

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: 2020-01-06 Expires: 2020-02-06

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IVDR Regulatory Affairs Manager

Kelly Services
Miami, FL 33126

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