Regulatory Affairs Specialist

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-381766

Yoh is hiring Regulatory Affairs Specialist (Level II or Senior Level)
for our Redondo Beach, Ca client. In the Regulatory Affairs Specialist
role, you will focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, ISO 13485, quality system auditing. They are seeking a highly motivated and independent specialist with strong skills in 510k submittals.

Industry: Medical Devices
Location: Redondo Beach, CA (onsite)
Compensation: $45- $50/hour (based upon experience)

R esponsibilities:

• Lead and support of US 510k Submissions
• Lead and support of Health Canada Device License Applications
• Lead and support of International Device Licensing and Registrations
• Support product development teams for new product submission requirements
• Product Technical Files development and maintenance
• Review and approval of ECOs related to assigned projects
• Has had experience with EU MDD and EU MDR
• Participate in Quality System Audits
• Technical writing
• Support UDI labeling project
• Managing and driving all aspects of international regulatory affairs from creation to submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) for product CE Marking and post-market follow-ups, amendments/supplements related to clinical trials under the new EU MDR (EU 2017/745).
• Supporting FDA regulatory with the creation, reviewing, editing, assembling and submission of domestic FDA regulatory documentation such as 510ks, Pre-subs, Letter-to-Files, IDEs, PMAs, etc. including regulatory responses and agency interactions.
• Overseeing the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacting with regulatory agencies to expedite submissions, and/or approval of pending registrations.
• Monitoring regulatory outcomes of initial product concepts and providing input to senior regulatory management.
• Collaborating with clinical operations to ensure clinical study results and reports are suitable for regulatory submissions.
• Responsible for adverse event (Vigilance, MDR) reporting and assessments of AE's to determine "reportable" events. Providing regulatory support as required in the evaluation of product complaints and ensuring AE reports meet regulatory requirements.
• Establishing and maintaining procedures relating to the MDR/CE Marking processes in accordance with MDCG, ISO, and applicable international and country-specific regulatory requirements.
• Serving as the regulatory liaison throughout product development lifecycle.
• Participating in some of the following: product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up.
• Ensuring alignment of regulatory strategy to business strategy across all functional areas including timely approval of new medical devices and continued expansion approvals of marketed products.
• Serving as a regulatory representative to marketing, clinical, research teams and regulatory agencies.
• Ensuring regulatory submissions and technical documentation meet appropriate standards, guidance, and content requirements.
• Advising development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations, and interpretations.
• Writing regulatory justifications to support design changes and submission filing decisions.
• May perform other duties as assigned.

• BS in Science related discipline
• 3-5 Years experience
• Strong skills in 510(k) submissions
• Experience with EU MDD and EU MDR