For our Regulatory department we are looking for Regulatory Affairs Manager.
Hybrid Position: combining work from the office and remote from home.
Job Description Summary:
The Regulatory Affairs Leader provides regulatory strategy to management regarding healthcare industry regulatory requirements for medical devices. Responsibility for Submissions to OUS (Out Of USA) countries.
Support product design development and changes, premarket submissions and registrations, and post-market compliance, while working closely with a cross-functional team and healthcare regulatory bodies globally. The Regulatory Affairs Leader brings regulatory expertise and combines it with in-depth understanding of key business drivers to lead a range of regulatory affairs activities
Responsibilities:
- Working in the Global Regulatory & Quality department
- Prepare submission documents
- Compile and maintain regulatory documentation databases or systems.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Follow/review Global Standards and prepare GAP analysis
- Develops regulatory strategy to optimize regulatory submission pathways, taking into consideration business priorities, regulatory requirements (e.g. product testing, clinical data), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
- Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
- Assesses changes in existing products and determines the need for new / revised licenses or registrations.
- Reviews and approves labeling
- Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions. Contributes to writing and editing technical documents
- Understands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance
Requirements
- Experience with regulatory Submissions in the Medical field
- Good organizational and project management skills to frequently coordinate complex activities
- Advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a bachelor’s degree from an accredited university or college.
- Minimum of 3 years’ experience working in a medical device company compliant to ISO 13485 and in a regulated field.
- Strong communication skills in English (both written and oral).
Desired Characteristic
- Strong communication, project management, and organizational skills.
- Ability to work independently in fast-paced environment and adapt to change.
- Ability to prioritize information for data analysis and recognize when additional information and support is needed
- Team-oriented and responsive to customer needs.
- Attention to Detail and Results-Oriented.
- Ability to understand technical documentation and execute associated procedures.
- Knowledge in Software and / or Multi-disciplinary medical devices (preferred)
Please send resume and cover letter to [email protected]