Sr. Regulatory Specialist, Regulatory Affairs
Wondfo USA
Wondfo is a known Point of Care company with global reach, striving to improve the quality of life and human health by developing and improving invitro diagnostic tests. At Wondfo USA’s site in San Diego, you will be supporting in manufacturing diagnostics tests for the healthcare market. We are currently seeking a Sr. Regulatory Specialist, Regulatory Affairs to fill an exciting position in our expanding R&D and Operation sites.
Responsibilities
- Develop and establish strategic regulatory plans and interfaces with project team members to drive corporate initiatives to completion.
- Represent regulatory affairs on project teams bringing novel products and manufacturing processes through product realization (from product concept to post market surveillance (including product development through market release).
- Develop and advance the organization's policy and procedures for regulatory affairs and regulatory compliance to establish a compliant culture.
- Maintain strong understanding of product distribution release processes and geography launch/maintenance requirements.
- Maintain strong understanding of product lines/disease states and customers.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Manage/prepare regulatory submissions including obtaining 510(k) product clearance and creating and maintaining other regulatory documentation as needed
- Ensure that product registration requirements are understood by project teams to obtain the required registration information
- Participate in an internal audit program/team to ensure all regulatory requirements are met.
- As needed, may review and approve Engineering/Document Change Orders (COs), design history file documentation including verification/validation, risk management documentation and labeling.
- Review and approve product labeling and marketing material including websites and social media. Initiate new package inserts and other required product labeling.
- Work with other departments (i.e., Customer Service, Marketing) to address external customers concerns and needs to distribute products onto the market
- Work with QA to coordinate and oversee post market surveillance activities (monitor the safety and effectiveness of products during the post-production phase).
- Process and review of MDRs, Vigilance Reports and Mandatory Problem Reports, and initiation & management of Corrections and Removals (C&R) activities.
Qualifications
- Bachelor’s degree in a Life Sciences discipline or equivalent
- At least five to ten (5-10) years relevant experience in Regulatory with IVD, Pharmaceuticals, or Medical Devices
- Proficient working knowledge of FDA regulations (specifically 21 CFR Part 820) and ISO 13485
- Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc.)
- Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness
- Strong interpersonal skills and ability to work as a team player
- Organized and detail-oriented, including ability to thoroughly document quality activities
- Ability to manage multiple projects with aggressive timelines
- Ability to work independently, within prescribed guidelines, or as a team member
- Demonstrated ability to follow detailed directions in a regulated environment
- Must be familiar with Microsoft Office (Word, Excel, Power Point) and Adobe (Reader/Creator) applications. Mastery of these tools is a plus.
- Bilingual preferred: Mandarin.