Job Summary:
Cook Device Solutions is in need of part-time/contract help support Quality & Regulatory Affairs for our clients in the medical device industry as outlined in the Job Responsibilities below.
Job Responsibilities:
- Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files.
- Manages communications with regulatory agencies and external partners.
- Manages the preparation of technical documentation and Quality Management System documents compliant with ISO13485, MDSAP Audit Approach, EU MDR 2017/745, and other international requirements.
- Participates in client internal audits and provides support for external audits.
- Assists in responding to requests for additional information from regulatory authorities and for international market registrations.
- Conducts post-market surveillance activities and writes subsequent reports.
- Maintains and updates device listings, device licenses, and establishment registrations for US and international markets.
- Applies applicable regulatory changes to client technical documentation and Quality Management Systems.
- Provides regular reports to clients on the status of regulatory submissions, licenses/clearances, and registrations.
- Supports day-to-day client quality and compliance activities as needed (e.g. Change Control, CAPA, Complaint Handling, etc.).
- Monitors budgeted hours and ensures projects are completed in an appropriate time frame.
Job Qualifications:
- Bachelors Degree in a related discipline
- 7+ years working in Medical Device industry
- 5+ years working in Regulatory Affairs
- In-depth knowledge of Risk Management and Design & Development activities
- Understanding of US, EU, and international regulations for medical devices
- Effective organizational skills and strong attention to detail in order to successfully oversee regulatory initiatives, multitask multiple client projects, and handle fluctuating workloads
- Well-developed interpersonal and communication skills (oral, written, computer-proficient) with the ability to independently manage clients and lead projects.
- Self-motivated, possess initiative, and able to work productively with minimal supervision
- Excellent project management and follow-up skills, deadline-oriented with a strong ability to prioritize tasks
We value the following qualities in all of our team members:
- High-quality standards, responsibility, and engagement
- Ability to interact with a range of personalities and many levels of the organization
- Demonstrated self-motivation and the ability to take initiative
- Project management and strong prioritization skills
- Adaptable to changing environment, client, and project needs
Job Type: Part-time, independent contractor
Location: Opportunity to work remotely with potential for travel on-site to clients, as necessary.
Job Types: Part-time, Contract
Pay: $100.00 - $175.00 per hour
Benefits:
Experience:
- Medical Device: 5 years (Required)
- Regulatory Compliance: 3 years (Required)
- EU MDR: 1 year (Required)
Willingness to travel:
Work Location: Remote
