We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Senior Regulatory Affairs Specialist, IVD Product Lifecycle responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies.
This position is focused on in vitro diagnostic systems including assay, software and hardware. The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.

Essential Duties and Responsibilities

• Independently support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team’s approved scope of regulatory activities, with focus on instrumentation and software/hardware, and experience in assay development.
• Demonstrated ability to interface with subject matter experts (SME) and regulatory agencies.
• Demonstrated ability to articulate regulatory risks, potential regulatory challenges, and optimal regulatory strategies.
• Prepare, compile and publish electronic pre-market and post-market regulatory submissions in approved geographical scope. Compile IVDR compliant Technical Documentation for IVD medical devices to support EU CE-Mark
• Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, EMEA, LATAM, Canada etc.).Prepare and maintain international submission dossiers.
• Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.
• Review of product labeling, materials for publication, literature and Web site for accuracy, consistency and regulatory compliance
• Develop and/or revise regulatory procedures
• Provide regulatory support to existing and new cross-functional product core teams
• Review new product design protocols related to verification and validation, risk assessment, etc.
• Mentor and instruct junior staff members on how to complete key regulatory activities such as submissions.
• Supervise and take responsibility for the quality of work completed by junior staff on shared projects.
• Support on-market regulatory activities as assigned by management.
• Assess and communicate new and/or updated regulations to technical functions within the company.

Required Qualifications and Experience

• Bachelor's Degree required in the life sciences or biomedical engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within the IVD or medical device industries OR Master’s Degree in biomedical engineering and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within the IVD or medical device industries.
• Software/instrumentation experience strongly preferred.
• Point of care molecular IVD test system experience preferred, with knowledge of instrumentation and assays

Other Related Skills:

• Demonstrated ability to coordinate complex projects.
• Strong oral and written communication and presentation skills with ability to participate in complex discussions
• Solid working knowledge of the US Regulations and European IVD and medical device regulations and directives
• Good analytical and problem solving skills.
• Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, with particular focus on laboratory automation and software/hardware components of IVD medical devices.
• Experience with point-of-care molecular IVDs highly desirable.
• Experience with International submissions and IVDs highly desirable.
• Experience working on developing syndromic multiplexed test panels highly desirable
• Capacity to communicate regulations to technical functions within the company
• Ability to manage relationships international customers (e.g., regulatory agencies, distributors, etc.)
• Solid computer skills in Microsoft Office

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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.

From a benefits perspective, you will have a access to benefits such as medical and dental insurance, ESPP, 401(k) plan, vacation, sick leave and holidays, parental leave, wellness program and many more!

The annualized base salary range for this role is $111,200 to $173,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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.

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