Regulatory Scientific Writer
: Job Details :

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

Our Regulatory Affairs department is looking for a Regulatory Scientific Writer here in San Diego! In this role, you will be developing wide-ranging knowledge in applicable disease areas and using those concepts to create new Performance Evaluation Plans (PEP) and Reports (PER) as well as reviewing, updating and refining existing performance evaluation documentation. You will also be responsible for:

* Obtaining and synthesizing scientific information related to clinical studies, analytical studies, post-market performance studies and external quality assessment testing and using this published and unpublished information to appropriately update PERs and post-market performance follow-up (PMPF) documentation determining if the device meets the requirements according to the IVDR.

* Working on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors to determine if the subject device performance is as expected, if there is a change in safety and if associated risks should be evaluated.

* Providing high-quality written deliverables on behalf of the Regulatory Affairs Department following appropriate regulatory guidelines and scientific writing standards.

Essential Duties and Responsibilities

* Creation and maintenance of Performance Evaluation documentation for IVDR compliance.

* Creation and maintenance of PMPF documentation as well as other IVDR Technical Documentation related documents essential for IVDR compliance.

* Critically assess subject device and comparator/competitor assay performance to determine the state of the art, scientific validity, clinical and analytical performance.

* Assess clinical practice guidelines for managing specific disease states/conditions.

* Generate and critically review documents and communications to be provided to regulatory bodies/Notified Body.

* Author or co-author functional area procedures and work instructions.

* Provide training to new team members (including consultants) on new processes and procedures, and work with other regulatory writers to share best practices, lessons learned, and support process improvement activities.

* Responsible for proactive management of deliverables assigned, communicating effectively, collaborating well with team members, active participation in team meetings, and attention to detail.

* Functions as a member of on-market Regulatory Affairs team to primarily support IVDR needs but may be asked to support other regulatory related items.

* Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation.

Required Education and Experience

* Doctoral or advanced degree (e.g., PhD, MD, PharmD etc.) strongly preferred, with at least 3 years of relevant industry and work experience

* Minimum of MS degree in a relevant medical/scientific field with at least 6 years of relevant industry and work experience

* RAC desirable

Skills

* Working knowledge of statistics in order to apply and understand appropriate study design methods and data analysis techniques for performance evaluation.

* Prior experience with IVDR documentation with a focus on Performance Evaluation.

* Knowledge and expertise with EU IVDR regulations, Health Canada and FDA.

* Experience with authoring scientific publications or industry related scientific writing skills.

* Experience in reviewing and synthesizing scientific literature and other relevant information to summarize key findings.

* Highly communicative.

* Can manage multiple documents simultaneously.

The annualized base salary range for this role is $114,600 to $179,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

#LI-RF1 #Mid-level

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.