21 days old

Sr Regulatory Specialist

Kelly Services
Somerville, NJ 08876
**Sr. Regulatory Affairs Specialist**

+ Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data

+ Ensure compliance with regulatory agency regulations and interpretations

+ Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines

+ Prepare responses to regulatory agencies' questions and other correspondence to resolve post submission queries ensuring timely approvals

+ Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed

+ Provide solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables

+ Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers

+ Guide conformance with applicable regulations in product development, support of claims and label content

+ Define data and information needed for regulatory approvals

+ Collaborate in the development and approval of labeling, 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 and systems

+ Represents Regulatory Affairs and provide regulatory advice on cross-functional project teams

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

+ Responsible for communicating business related issues or opportunities to next management level

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all

+ Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

+ Performs other duties assigned as needed


+ Minimum of a Bachelors degree

+ Advanced degree (MS, PhD, MD or Pharm D) (preferred)

+ 4 to 7 years of experience in medical device industry regulatory affairs

+ Must be experienced in authoring/submitting Regulatory Submissions

+ Experience with maintaining a variety of regulatory affairs database systems.

+ At least 4 plus years of hands-on experience with filing required regulatory documents with the US FDA and/or appropriate government agencies.

+ Demonstrated experience with Health Authority interactions and understanding of regulatory processes.

+ Proven track record of project management skills.

+ Excellent interpersonal skills, ability to manage conflicting points of view and negotiate an appropriate resolution to issues, while ensuring compliance with applicable regulations.

+ Good communications skills, both written and verbal.

+ Must be able to convey scientific and sometimes complex issues in a clear concise manner to ensure understanding across a very diverse employee population.

**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: 2022-09-12 Expires: 2022-10-13

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Sr Regulatory Specialist

Kelly Services
Somerville, NJ 08876

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