Regulatory Affairs Specialist

Hologic, Inc.; San Diego, Northern (CA, KY); Hybrid; USD 74,000 - 116,000; Full time

Job summary

Hologic, Inc. is seeking a Regulatory Affairs Specialist to manage moderately complex regulatory projects and provide guidance on global regulatory requirements for new and existing products.

The role covers change assessments for manufacturing, labeling, and process changes across Cytology and Molecular lines. You will prepare international submission dossiers, post-market reports, and EU CE-Mark documentation while interfacing with development teams and authorities throughout the product

Qualifications

• Bachelor’s Degree required in the life sciences or engineering with a minimum of 4 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred).
• Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry

Responsibilities

• Participate in product development project teams which include new or existing products as the regulatory representative and provide guidance on global regulatory requirements for new/existing products
• Assess manufacturing process, design, and labeling changes regulatory assessments and global change management for manufacturing changes associated with the Cytology and Molecular product lines.
• Prepare and maintain international submission dossiers
• Prepare, compile and publish post-market regulatory submissions
• Compile and / or maintain Technical Documentations for IVD medical devices to support EU CE-Mark
• Interact with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America, Europe, the Middle East and Africa, Canada etc.).
• Monitor progress on key project deliverables and provide status updates to management on a regular basis.
• Review validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions
• Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle
• Provide recommendations for compliant advertising/promotional materials
• Keep informed of new and revised regulations; disseminate information as appropriate.
• Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
• Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices
• Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).

Skills

Project coordination

Regulatory knowledge

Communication skills

Lifecycle understanding

Microsoft Office

Education

Bachelor’s degree in life sciences or engineering

Master’s degree and RAC (preferred)

Tools

Agile

Oracle

Job description

Regulatory Affairs Specialistmanages assigned projects of moderate complexity which includeinternational regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

Essential Duties and Responsibilities

• Participate in product development project teams which include new or existing products as the regulatory representative and provide guidance on global regulatory requirements for new/existing products
• Assess manufacturing process, design, and labeling changes regulatory assessments and global change management for manufacturing changes associated with the Cytology and Molecular product lines.
• Prepare and maintain international submission dossiers
• Prepare, compile and publish post-market regulatory submissions
• Compile and / or maintain Technical Documentations for IVD medical devices to support EU CE-Mark
• Interact with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America, Europe, the Middle East and Africa, Canada etc.).
• Monitor progress on key project deliverables and provide status updates to management on a regular basis.
• Review validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions
• Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle
• Provide recommendations for compliant advertising/promotional materials
• Keep informed of new and revised regulations; disseminate information as appropriate.
• Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
• Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices
• Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).

Qualifications

Education & Experience

• Bachelor's Degree required in the life sciences or engineering with a minimum of 4 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred).
• Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry

Skills

• Demonstrated ability to coordinate complex projects.
• Understanding of medical device and IVD regulations in US and international markets.
• Capacity to communicate regulations to technical functions within the company
• Understanding of product life cycle process, design control and/or risk management.
• Experience with document control systems such as Agile and Oracle
• Ability to work independently and effectively
• Strong oral and written communication skills with ability to write detailed information for submissions
• Good analytical and problem solving skills.
• Ability to make and keep time bound commitments for project completion
• Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
• Strong interpersonal skills including the ability to interact with all levels of the company
• Ability to manage relationships international customers (e.g., regulatory agencies, distributors, etc.)
• Strong computer skills including Microsoft Office

The annualized base salary range for this role is $74,100 - $116,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

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.

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