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Job

Director of Regulatory Affairs

  • Location

    Pacific Northwest

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Avita Broukhim

  • Contact email:

    a.broukhim@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2019-09-08

  • Startdate:

    ASAP

My client is a leading IVD/Diagnostic/Medical Device company that is looking to expand the Regulatory team by adding a highly qualified Director of Regulatory Affairs.


The Director of Regulatory Affairs at this exciting and growing company is responsible for leading regulatory affairs department daily activities by preparing relevant regulatory filings to the FDA and global regulatory authorities, with a focus on respective companion diagnostics. Some important aspects of the position include managing the life-cycle of products in the pipeline that are marketed as well as in development, maintaining needed registrations and certifications, and making sure the regulatory strategy is aligned with corporate strategy in conjunction with senior management.

The Director of Regulatory Affairs has company-wide influence and functions as an internal expert resource. The individual will be actively called upon to provide regulatory guidance to business unit leadership and project teams.

Key Responsibilities Include:

  • Developing and implementing regulatory strategies to achieve global regulatory approval timelines for new products and feature enhancements
  • Guiding regulatory affairs staff to successfully participate in product design teams
  • Creating, evaluating, and updating Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced, and guides staff in these activities
  • Reviewing labeling/promotional/advertising materials, and other documents to ensure compliance, and guides staff in these activities
  • Maintaining current knowledge of relevant regulations, including proposed and final rules. Interpreting RA policies and guidance and correctly apply them as regulatory processes, and guiding staff in these activities
  • Representing regulatory affairs as part of cross functional teams resolving on market product issues including complaints, CAPA, MDRs and field actions. Providing regulatory input during audits and in adverse event reporting
  • Coaching, developing and motivating the team to build a sustainable pipeline of leaders for the organization. Acting as a model leader in the organization

Qualifications And Requirements (Education, Experience, Specific Skills)

  • BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
  • Previous in vitro diagnostic (IVD) nucleic acid experience, companion diagnostic (CDx), and life science products for translational research experience highly preferred
  • 10+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
  • Minimum 3 years direct people management experience
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Strong knowledge of FDA QSR and ISO 13485 regulations
  • Experience directly working with the FDA to through the submission process and to resolve on market issues
  • Experience in a Molecular Biology research environment
  • Certifications: RAC, CQA, CQM preferred
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Strong organizational skills and ability to support multiple projects
  • Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
  • Proven ability to motivate and develop junior staff