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20 days old

Regulatory Changes Program Lead (Remote, EST)

Kelly Services
Raynham, MA 02767
**Regulatory Changes Program Lead**


Kelly Science and Clinical FSP is currently seeking a **Regulatory Changes Program Lead for a long-term remote (EST) engagement** with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


The Regulatory Changes Program Specialist is responsible for the regulatory management and delivery of franchise-specific outputs for global implementation of changes related to MDR (responsibilities exclude CE mark and USA). This role requires the development of a comprehensive RA strategy and execution of the strategy in all additional markets in which product is offered.


**In this role, you will:**

Develop, maintain, and execute comprehensive RA strategies related to MDR changes for Global regulated markets (excluding CE mark countries and USA).

Collaborate with Franchise RA and Supply Chain to set the registration schedule and then execute against it.

Manage and support operational teams by establishing and maintaining essential processes, keeping products compliant with local country requirements by ensuring that products receive country approvals and internal operational systems such as MDRIM and RAD are updated to minimize impact on Supply Chain effectiveness and product disruptions.

Provide regional RA partners with project deliverables and support global registration activities as necessary

Create, maintain, and communicate appropriate program reports and presentation to meet business goals and program objectives.

Work with the franchise Regulatory and Global Supply Chain representatives to define the timelines and requirements for country registrations and execute accordingly.

Focus on IT Systems (MDRIM) coordination and close liaison with resource to ensure timely solutions to registrations through product eligibility (i.e. product release via RAD)

Identify business process owners and align and implement process changes, identify risks and issues to escalate as necessary.



**Qualifications:**

A minimum of a Bachelors degree with at least 5 years working in the medical device, pharmaceutical or regulated industry is required.

At least 3 years of experience working in a complex matrix environment is required.

At least 3 years working in Regulatory Affairs or related area is preferred

Working knowledge of regulatory requirements, processes, and terminology is required.

Experience in working at the interface between systems, processes, and business is preferred.

Demonstrated written and verbal communications skills in English, able to quickly build credibility within Franchises and Regions is required.

Demonstrated project management skills and data analysis skills




**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-16 Expires: 2022-10-17

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Regulatory Changes Program Lead (Remote, EST)

Kelly Services
Raynham, MA 02767

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