Senior Regulatory Affairs Specialist

POSITION SUMMARY:

The Senior Regulatory Affairs Specialist plays a key role in supporting the effective implementation of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. The position combines a growing technical knowledge and understanding of regulatory requirements within at least one area regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, Japan, or China to support the approval and registration of Natera’s products and services. Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line.
May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities. Supports overall effectiveness of the regulatory affairs team at Natera through contributions to staff development, process improvements and understanding of current regulatory requirements. Uses project management skills to support the RA team in timely completion of assigned actions.

PRIMARY RESPONSIBILITIES:

• Understand and implement regulatory strategy based on existing guidance documents within a particular area of IVDs either CLIA/CAP/NYS, US FDA or EU IVDR. Provide summaries and educational awareness within project subteams or in support of project planning.

• Support preparation of pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements; Work closely with RA leadership to prepare analytical and clinical pre submissions that advance project goals.

• Support regulatory submissions for in vitro diagnostic devices including IDEs, EU/IVD Technical Documentation, classification requests, pre-submissions, and updates to registrations worldwide.

• Support regulatory affairs efforts in new and existing technology project teams to implement regulatory strategy and meet regulatory requirements towards overall success of the project
  deliverables.

• Represent Regulatory Affairs in written communication with regulatory authorities

• Contribute to regulatory plans and regulatory change assessments that meet CAP/CLIA/NYS, US IVD, EU IVDR and international requirements.

• Collaborate within the RA team to implement least-burdensome approaches and facilitate time-to-market for Natera products and services.

• Support regulatory deliverables on behalf of internal and external program teams.

• Build specialized knowledge of regulatory guidelines and requirements within one or more
  fields applicable to Natera; maintain excellent records of regulatory interactions and reports, contribute to the effectiveness of the RA team

• Support RA leadership in implementation of data-driven improvements in RA processes, acquisition of cross-functional leadership skills and core competencies in regulatory affairs.

• Contribute to the setting of individual and departmental annual goals aligned with business objectives

• Other duties as assigned

QUALIFICATIONS:

• Associate’s degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education

• 3-5 years of work experience in Biotech industry preferred or a relevant combination of skills, education, and experience

• RAC preferred
   

KNOWLEDGE, SKILLS, AND ABILITIES:

• Computer skills (MS Word, Excel, PowerPoint, etc.)

•  Good technical writing and communication skills, independent worker, a self-starter with strong organizational and planning skills

• Has an ability to be productive and successful in an intense work environment

• Demonstrates good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects