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22 days old

Regulatory Affairs Specialist, Medical Device

Kelly Services
Raynham, MA 02767
Kelly is currently seeking a Regulatory Affairs Specialist for a long-term engagement with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. 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.


**OVERALL RESPONSIBILITIES:**


Serves as a consultant and technical expert on Regulatory Affairs matters.


Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.


**P** **O** **SITION DUTIES & RESPONSIBILITIES:**


Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities


Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.


Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.


Defines data and information needed for regulatory approvals.


Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.


Provide Regulatory Affairs support during internal and external audits.


Plans schedules for regulatory deliverables on a project and monitors project through completion.


Assists in the development of best practices for Regulatory Affairs processes.


Represents Regulatory Affairs on cross-functional project teams.


Partners with other functions to define and obtain data to assist with regulatory submissions.


**Functional and Technical Competencies:**


Excellent written, verbal communication and presentation skills


Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life- cycle management of products.


Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives.


Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class II and III devices (EU and USA 510k).


Ability to partner and influence key stakeholders on NPD and Lifecycle teams.


Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).


Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.


Ability to author and submit US, EU and International Regulatory submissions to Regulatory bodies.


**Leadership Competencies:**


Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels


Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives


Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions


Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances


**EDUCATION & EXPERIENCE REQUIREMENTS:**


BSc or equivalent working experience


Practical experience with the preparation and submissions for Class II and III medical devices EU MDD and MDR.


+ Experience of change management determining impact to EU and USA approvals.


Substantial experience of EU and International Regulations required.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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Regulatory Affairs Specialist, Medical Device

Kelly Services
Raynham, MA 02767

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