Relievant’s Sr. Regulatory Affairs Specialist will be helping to advance the company’s minimally invasive low back pain technology. This position is responsible for regulatory affairs department deliverables and communicating with regulatory agencies in alignment with the company’s strategic goals, objectives, resources, and priorities. This individual will support a growing environment focused on regulatory approvals and compliance issues that impact Relievant Medsystems, Inc. and its customers.
- Communicates with US FDA, EU Notified Bodies, EU Competent Authorities, and other international regulatory authorities
- Coordinates/prepare and maintains FDA 510(k) Premarket Notifications in accordance with US FDA requirements
- Prepares and maintains Technical Files / Technical Documentation for MDD and MDR compliance
- Manages Essential Requirement checklists
- Assures timely updates for all applicable CE certifications
- Identifies, prepares and submits required MDR reports
- Coordinates and prepares responses to FDA, Notified Body and/or other regulatory agencies
- Prepares annual FDA product registrations, listings and required applications
- Partners with quality assurance, R&D, manufacturing, and marketing to ensure product compliance and timely product clearances and/or approvals.
- Contributes as regulatory affairs team member on product development projects
- Provides regulatory guidance and guidance on applicable standards to cross-functional groups
- Assists with the development of global regulatory strategies and regulatory plans
- Supports reviews of product labeling changes
- Reviews / approves promotional and marketing materials
- Support CAPA and CAPA closures
- Identifies new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company and presents at Management Review Meetings
- Participates in regulatory audits/inspections as required
- Writes SOPs and trains personnel as needed
- Perform other duties as assigned
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to demonstrate versatility, flexibility, and a willingness to work within constantly changing priorities in a rapidly growing company with enthusiasm.
- Must be able to recognize and anticipate departmental needs and initiate and recommend actions
- Knowledge of U.S. and European/International regulations and standards
- Must have proven writing skills
- Solid understanding of product development, manufacturing and change control, and an awareness of regulatory trends
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Basic understanding of computer applications
- Familiarity with medical terminology
- Superior interpersonal skills including communication skills, both oral and written
- Where permitted by applicable law, employees of Relievant Medsystems are required to be fully vaccinated against COVID-19 as a condition of employment. If an applicant is unable to be vaccinated due to a medical condition or a sincerely held religious belief, practice or observance, Relievant may provide reasonable accommodations.
Education / Experience:
- Bachelor’s degree (minimum)
- 3+ years of regulatory experience in the Medical Device Industry
- Experience with medical device regulatory submissions – 510(k)
- Experience with in-depth understanding of quality management systems in FDA, ISO 13485, and MDD/MDR regulatory environment
- Previous experience working with Regulatory Authorities
- Regulatory Affairs Certification a plus
- Demonstrated experience in producing effective and timely regulatory affairs deliverables.
- Solid understanding of regulatory affairs principles and professional communications.
- This position is in Sunnyvale, California. We provide a flexible hybrid work model that includes days working from our corporate office and remotely.
We are proud to offer our employees an excellent compensation and benefits package and we are an equal opportunity employer.
For more information or to apply, please add the name of the position in the subject line along with your resume to: email@example.com.