Senior GRC Consultant consulting clients on GRC software RiMaGo and implementing risk strategies. Collaborating with development team and conducting training sessions in GRC.
About the role
- Senior Regulatory Affairs Specialist managing regulatory submissions and compliance for medical devices in the healthcare industry. Collaborating with cross-functional teams on product development and lifecycle management.
Responsibilities
- Implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes.
- Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing.
- Represents the company in discussions with regulatory bodies and industry groups.
- Responsible for collaborating, planning and executing regulatory activities related to the Microstream™ Capnography Monitoring product portfolio.
- Participation in change development projects, review and approve design control documentation, regulatory change assessments.
- Author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation.
- Translate regulatory requirements into project/product requirements and ensure timely and high-quality execution of assigned regulatory deliverables.
Requirements
- Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices.
- A Regulatory Affairs qualification is desirable, but not mandatory.
- Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
- Strong technical knowledge.
- Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
- Experience with software and hardware medical devices.
- Dynamic team player and can work effectively and pro-actively.
- Ability to comprehend principles of engineering, physiology, and medical device use.
- Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate.
- Excellent attention to detail and results oriented.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
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