Regulatory Affairs Specialist

Hologic•San Diego, CA

1d•$74,100 - $116,000

About The Position

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

Requirements

Bachelor's Degree required in the life sciences or engineering.
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.
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.

Responsibilities

Participate in product development project teams as the regulatory representative and provide guidance on global regulatory requirements for new/existing products.
Assess manufacturing process, design, and labeling changes for 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).