The Regulatory Affairs Specialist will provide Regulatory Affairs (RA) support for product remediation projects, process and systems remediation projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. This role will provide support for global product registrations and related regulatory affairs activities, as the need arises. This role will appropriately execute project activities based on applicable products and systems which are designed to ensure that the product development process adheres to all regulatory requirements as well as objectives to the business. The candidate is encouraged to utilize project planning skills to initiate, plan, and execute regulatory projects and submissions with support of supervisor. The candidate must be able to manage change and be flexible when providing solutions. The candidate will be expected to collaborate with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships.
Essential Job Functions:
Understands and has solid understanding of European Medical Device Regulations. Supports US and international product submissions/registrations, as needed.
Participates in product core teams as the need arises to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around remediation goals.
Initiates and updates regulatory registrations as required and per applicable SOPs.
Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
Provides general support for regulatory team and special projects, as needed.
Assists in the preparation of division procedures to ensure compliance with EU MDR, and other Regulatory and Corporate requirements.
Ensures adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards. Ensures maintenance of regulatory documentation.
Excellent written and oral communication skills.
Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook).
Demonstrated problem solving and analytical skills.
Ability to plan and schedule multiple priorities in a concurrent fashion.
Ability to review, collate and summarize scientific and technical data.
Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
Proven project management skills.
Experience working with others in a team environment.
Education & Experience:
This position requires a bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering, or medical-related field.
2+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred.
Experience with European Medical Device Regulations is preferred.
Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment: BDPI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.