The Senior Regulatory Affairs (SRA) will assume responsibility for the independent preparation and submission of international product registrations for US and Rest of World (ROW) countries.
The SRA is also responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices in International and US regions.
The RAS translates regulatory requirements into project/product requirements and will prepare regulatory submissions and negotiates their approval with regulatory agencies as required.
Primary responsibilities include: Preparing ROW documentation required for licensing of company’s products; Preparation of Technical Files, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, while ensuring timely and high-quality execution of assigned regulatory deliverables.
Scope of function:
- Plans and prepares regulatory submission documents for US and OUS regulatory filings under minimal supervision.
- Prepares documentation that is complete and accurate.
- Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
- Assist in the development of RA strategy for new products and design changes – ensuring regulatory requirements for target markets are met.
- Participates in audits and inspections of the company and its quality systems.
- Team with business unit to provide regulatory support for new products and changes to existing products. Work with the technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Preparation and maintenance of annual renewals of Establishment Registrations, States licenses, Device Listing, and other domestic and international licensing.
- Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
- Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
- Determination of regulatory submission requirements according to domestic and international regulations related to changes/new products/claims.
- Maintain technical knowledge of devices in area of responsibility.
- Maintain up to date on global regulatory requirements and assist in keeping company informed of changes.
- Review and update SOPs, as needed
KNOWLEDGE, SKILLS AND ABILITIES:
- Deep understanding of FDA and international regulations.
- Strong working knowledge of medical devices regulations and terminologies.
- Excellent written and oral communication, and technical writing and editing skills.
- Ability to write clear, understandable technical documentation.
- Skilled at analyzing and summarizing data.
- Ability to manage and prioritize multiple projects.
- Ability to follow written and verbal directions with a high level of accuracy.
- Ability to work independently with minimal supervision.
- Attention to detail with ability to work in a team setting.
- Ability to effectively manage multiple projects and priorities.
- Effective interpersonal skills.
Bachelor’s Degree in chemistry, scientific or engineering discipline with of 5 to 7 years of related experience is required.
Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13485) and Medical Device & IVD Regulations (EU MDR 2017/745 and EU IVDR 2017/746)
EDUCATION AND EXPERIENCE:
- RAC Certification is a plus
- US, Health Canada, EU submission experience
- • International medical device regulatory submission/approval experience including US, EU, Canada, Japan, China and ROW
- Ability to work in a dynamic environment
- Ability to efficiently operate all job-related office equipment
- Ability to communicate via telephone and work in virtual teams
- Ability to work in a traditional professional office setting or remote equivalent