Regulatory Affairs Specialist 1 CR

Job Summary:

A Regulatory Affairs Specialist I, based at the Hologic Costa Rica site, who provides global regulatory support to cross-functional teams working on Hologic GSS products. This position serves as a key liaison between the Hologic GSS regulatory team and the Hologic Costa Rica manufacturing site, working to bridge communications and enhance cross-functional collaboration with local stakeholders. The position has primary responsibility for regulatory support and guidance for on market products manufactured at the Hologic Costa Rica site to ensure continued market access for medical devices. Works to ensure that regulatory requirements continue to be met and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Quality, and Operations, and to ensure effective communication and alignment between the manufacturing site and legal manufacturer.

Supports the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewals and annual registrations. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Supports product release process.

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.

Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Normally receives detailed instructions on all work.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Participates in Value Improvement Projects and supports cross functional teams by performing change assessments, relaying regulatory strategies and ensuring projects comply with appropriate regulations.
• Support preparation and compilation of document packages for regulatory submissions, audits and inspections.
• Support maintenance of regulatory databases and technical files.
• Participate in developing or improving processes, procedures and standards that contribute to meeting internal SOP's, regulatory and industry regulations.
• Maintains current knowledge of existing and emerging regulations, standards, and laws.

Physical Demands:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Sit; use hands to finger, handle or feel objects, tools, or controls.

• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

• Lifting/moving and carrying products weighing up to 40 pounds.

• Exposure to moving mechanical parts, vibration and/or moderate noise levels.

• Exposure to hazardous chemicals or other materials.

• Safety Shoes with Impact and Compression Protection Must be worn in designated areas.

• Exposure to blood.

• Travel (please specify):

• Other (please specify):

Qualifications:

Education

• Bachelor's degree engineering or related field or equivalent.

Experience

• Excellent communication in both English and Spanish, including verbal, technical writing, interpersonal and presentation skills.

Skills

• Proficient with technology applications such as MS Office.
• Strong data and statistical analysis skills and ability to use data to make informed recommendations.
• High degree of attention to detail
• Ability to take direction and apply problem solving skills.
• Regulatory Affairs Certification (RAC) is beneficial.
• Project Management Experience is beneficial.