Senior Regulatory Affairs Advisor

Job Summary:

Cook Device Solutions is in need of a full time Senior Regulatory Affairs Advisor 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 ISO 13485, 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
• 5+ years working in Medical Device industry
• 3+ 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: Full-time

Location: Opportunity to work remotely or in Indianapolis, Indiana office.

Job Type: Full-time

Pay: $100,000.00 - $125,000.00 per year

Benefits:

• Paid time off
• Retirement plan

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Application Question(s):

• What are you looking for in your next role?

Experience:

• Medical Device: 5 years (Required)
• EU MDR: 1 year (Required)
• Regulatory Compliance: 3 years (Required)

License/Certification:

• ISO 13485 auditing certification? (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: Remote