Staff Regulatory Affairs Specialist

Embecta • Parsippany-Troy Hills, NJ

98d • $126,600 - $1,681,000 • Remote

About The Position

This position will be responsible for providing regulatory strategies and execution on embecta growth initiative projects. The role will support full product life cycle management activities which include identification and interpretation of regulatory requirements, review and preparation of regulatory submissions required to market new or modified devices in both the U.S. and Europe, and related regulatory affairs activities to ensure compliance with regulations and alignment with the objectives of the business. This role will also represent regulatory affairs and provide leadership across multiple project development teams by interpreting and guiding teams on global requirements, working closely with cross-functional partners and international regulatory groups.

Requirements

• B.S. degree in a scientific, health science, or technical discipline (e.g. engineering, bioengineering, biology, chemistry).
• 5+ years Regulatory Affairs experience in medical device companies.
• Must have current knowledge of the U.S. and European Medical Device regulations.
• Demonstrated success in the preparation and completion of 510(k) and EU MDR regulatory submissions to FDA and EU notified bodies.
• International product registration experience.
• Proficient in using Microsoft Word, Excel and PowerPoint.

Nice To Haves

• Advanced degree desirable.
• RAPS (RAC) Certification preferred.
• Excellent interpersonal, communication (oral and written) and analytical skills.
• Ability to work in a global team environment, manage multiple projects, and prioritize effectively.
• Extensive knowledge of global regulations and product development processes including design controls.
• Must have strong critical thinking and technical writing skills.
• Must be able to handle and prioritize multiple tasks and have excellent attention to detail.
• Experience negotiating with Health Authority personnel in the medical device area.
• Demonstrated global perspective, customer focus, problem solving, cross-functional collaboration and teamwork skills.
• Demonstrated ability to resolve problems.
• Ability to work independently to achieve objectives on or before schedule.
• Strong decision-making skills with experience working in a fast-paced environment.
• Strong communication, negotiation, influence and project management skills.
• Demonstrated cross-functional collaboration and teamwork skills including influencing without authority.
• Must be self-motivated by working independently and having the ability to take ownership of responsibilities.

Responsibilities

• Monitor worldwide regulation/standard developments to identify and communicate quantified/anticipated risks and mitigation approaches associated with regulatory strategies.
• Coordinate, prepare, and complete premarket applications to the US FDA, including 510(k) submissions, in a timely manner.
• Assess necessity for submitting a 510(k) application for proposed device changes.
• Prepare internal 'Non-Filing Justifications' (U.S.) for changes that do not require a 510(k) submission.
• Coordinate and prepare technical files for submission to European Notified Bodies for timely EU MDR approval of new and modified products with appropriate input from various functions (R D, Quality, Manufacturing, Medical Affairs, etc.).
• Assess and manage submission of notification of change to the Notified Body about significant changes to CE marked products in a timely manner.
• Support International Regulatory Associates as it pertains to registering our devices worldwide.
• Review/approve label/labeling, promotional and advertising materials to ensure compliance with applicable laws, regulations, and company policies.
• Ensure FDA product listings and facility registrations are submitted and maintained.
• Coordinate and respond to requests for FOI, product information, and questionnaires requested by customers.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis to maintain compliance with applicable regulations and standards.
• Identify ways to improve the efficiency of the current work process and implement them.
• Carry out the above tasks with minimal supervision.

Benefits

• Medical, dental, vision insurance.
• Retirement savings plans.
• Paid time off.
• Annual bonus eligibility.

What This Job Offers

• Education Level: Bachelor's degree