What are the responsibilities and job description for the Compliance Specialist IV position at OrangePeople?
Job Details
OP, we're more than a consulting firm- we're a people-first, high-touch organization committed to delivering transformative technology solutions with integrity and passion. We are seeking a Compliance Specialist who will be a dedicated resource for a leading global social media company.
Responsibilities:
- This subject matter expert will work cross-functionally in a tech company.
- The ideal candidate will act as the leader for the growing Medical Devices QMS team, draft SOPs, technical documents and have deep domain experience in digital health and software as a medical device (SaMD).
- Leverage operational experience to meet quality and regulatory goals, define processes within a medical device product area residing within a larger consumer electronics division.
- Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products.
- Collaborate with systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and device master record (DMR) deliverables.
- Guide medical device development teams in their execution strategy for Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports).
Qualifications:
- Bachelor's Degree in Technical Science, min MS degree in quality assurance or equivalent.
- 6 to 8 years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development).
- Experience in the application of ISO 13485, ISO 14971, 21 CFR 820, and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR.
- Experience authoring technical reports, business correspondence, and standard operating procedures.
- Proven communication skills.
- Experience presenting clearly and persuasively to technical and non-technical audiences.
Benefits:
- 401(k).
- Dental Insurance.
- Health insurance.
- Vision insurance.
- We are an equal-opportunity employer and value diversity, equality, inclusion, and respect for people.
- The salary will be determined based on several factors including, but not limited to, location, relevant education, qualifications, experience, technical skills, and business needs.
Additional Responsibilities:
- Participate in OP monthly team meetings, and participate in team-building efforts.
- Contribute to OP technical discussions, peer reviews, etc.
- Contribute content and collaborate via the OP-Wiki/Knowledge Base.
- Provide status reports to OP Account Management as requested.
About us:
OP is a technology consulting and solutions company, offering advisory and managed services, innovative platforms, and staffing solutions across a wide range of fields - including AI, cyber security, enterprise architecture, and beyond. Our most valuable asset is our people: dynamic, creative thinkers, who are passionate about doing quality work. As a member of the OP team, you will have access to industry-leading consulting practices, strategies & and technologies, innovative training & education. An ideal OP team member is a technology leader with a proven track record of technical excellence and a strong focus on process and methodology.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
