Position Overview:
The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.
Location: Brea, CA
Shift: M-F, standard working hours
Hybrid Role
Pay: 45/hr
6-8 month contract role
RESPONSIBILITIES:
- Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
- Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
- Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
- Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company
- Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Technical writing of procedures and/or SOPs that link to the regulatory operations
- Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects
- Responsible for the implementation of regulatory strategies and ensures timely registration of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and existing products in regulated markets (i.e. US, Canada, Asia-Pac, LATAM, Russia/CIS, China, and MEA-T)
- Coordinates, prepares, and maintains regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regions
- Maintains approvals/licenses/authorizations for existing marketing authorizations
- Complete regulatory assessments and audits of product, manufacturing, Quality Management System (QMS) and labeling changes to assess impact to the user/patient, regulatory reporting, and compliance to regulations
REQUIREMENTS:
- Bachelor’s degree in a scientific discipline and 4-6 years of work experience in RA role within Medical Device industry. OR
- Master’s degree and 2 years work experience in RA role within Medical Device industry.
- Experience authoring 510(k)s, PMA, Health Canada and/or EU Technical File submissions for medical devices preferred
- Demonstrated experience serving as lead RA representative on cross-functional teams supporting new product development; SaMD experience a plus.
