Kelly Services - Brea, CA
posted about 2 months ago
Full-time - Mid Level
Brea, CA
Administrative and Support Services
About the position
The Senior Regulatory Affairs Specialist is responsible for creating, evaluating, and completing regulatory tasks related to worldwide product registration submissions, facility registrations, and FDA submissions. This role involves obtaining global regulatory clearances and approvals, collaborating with cross-functional teams, and ensuring compliance with country-specific requirements throughout the product development lifecycle.
Responsibilities
- Assist in the development of RA strategy for new products and design changes, ensuring regulatory requirements for target markets are met.
- Actively participate in defining customer requirements, product claims, and target markets early in the product development lifecycle.
- Prepare and maintain technical files, MDD/MDR certifications, and declarations of conformity in support of EU product registrations/CE mark.
- Maintain current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company.
- Create and implement 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.
- Represent and provide regulatory guidance within the cross-functional team and serve 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.
- Coordinate, prepare, and maintain regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regions.
- Maintain 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.
- 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Telemedicine
- Term life insurance
- Whole life insurance
- Accident insurance
- Critical illness insurance
- Legal plan
- Short-term disability
- Retirement savings plan
- Service bonus
- Holiday pay plans
- Transit spending account
- Paid sick leave
