Regulatory Affairs Associate Director

Hampton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Regulatory Affairs Associate Director in Hampton, New Jersey. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Interprets and applies applicable laws, regulations and guidelines governing devices and drugs, to meet business objectives
  • Formulates and implements regulatory strategies, in conjunction with business objectives, and translates plans into operational deliverables (i.e. submissions)
  • Assesses and communicates device regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines
  • Manages regulatory activities in respect to quality and timeliness
  • Interacts with health authorities on guidance, submission and review of device products and projects Directs the preparation of and prepares worldwide device submissions to health authorities and ensures the quality and content of submissions
  • Advises the Project Teams on regulatory issues concerning tproject deliverables
  • Partners with internal departments and ensures development plans meet regulatory requirements and guidelines
  • Considers and recommends any necessary changes to policies and procedures to ensure regulatory compliance

EXPERIENCE

 8 to 10 years regulatory affairs experience in the medical device industry

EDUCATION

Bachelor’s degree in a scientific discipline

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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