Senior Regulatory Affairs Specialist (m/w/d) - Medical Devices
Job Description SummaryThe Regulatory Affairs International Specialist is responsible for developing regulatory strategies, preparing international regulatory submission deliverables, and obtaining and maintaining approvals necessary to market products. The candidate works closely with in-country Regulatory colleagues to prepare agency submissions and with other functional areas to provide timely responses to regulatory questions in support of product approvals. The candidate must be able to manage change and be flexible when providing solutions.
About the Role
- Defining the regulatory strategy and manages regulatory submission activities for new product development activities and product maintenance for existing approved medical devices.
- Planning, coordinating, creating, and providing deliverables to international colleagues to support new product (Medical Devices) registrations, license renewals and change submissions.
- Works with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Managing registration database content to support new and on‐going International requests. Maintains database to ensure deliverables are accurate and up to date to ensure International regulatory submissions are accurate
- Initiating and updating regulatory registrations as required and per applicable SOPs.
- General support for regulatory team and special projects, as needed.
- Interpretation for new and changing regulatory requirements, communicates impact to stakeholders, and develops implementation plans.
- Ensuring adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards. Ensures maintenance of regulatory documentation.
- This position requires a Bachelor’s degree or advanced degree in a technical area such as engineering, physics, chemistry.
- 2+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred.
- Regulatory Affairs experience with international submissions.
- Knowledge of the NMPA (China) requirements (preferred)
- Work Environment: BDPI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. Candidate must be able to work in a team-oriented, fast-paced environment.
- Excellent English written and oral communication skills
- Proven computer skills (MS Windows 10 and Office Suite)
- 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.
This position is based in Karlsruhe with the opportunity to work remotely 3-4 days of a 5 days work week.
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
Primary Work LocationDEU Karlsruhe
Recommendto a friend
"I like being able to make a difference. Working at BD is an opportunity where the products save lives every day."
Current Employee - Anonymous, Limerick