Sr Manager, Regulatory Affairs
In this role, you have the opportunity to:
Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
You will manage a team of 7 people. The team is located in the Germany, India and USA. The managing part is about 40% of the work. The main part of the work is related to RA projects and support New Product Introductions.
You are responsible for:
- Managing a multicultural Regulatory Affairs professionals based in Hamburg, Germany, Pune, India and Fitchburg, Wisconsin, USA
- Key program/project deliverables by developing Regulatory project plans.
- Participates in program/project meetings to provide guidance on the worldwide regulatory requirements for medical devices.
- Responsible for product registrations/approvals.
- Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of company, and participates in external government product audits by China, Korea, Japan and other inspection agencies as needed.
- Compiles all materials required in submissions, license renewal, initial product reports and annual product reports.
- Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
- Keeps abreast of current regulatory procedures and changes.
- Participates in direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
- Regulatory Affairs representative for the Diagnostic X-ray Systems and software and to assist with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
- Defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
- Coordination and preparation of document packages [510(k) Pre-market Notifications, Technical File and Design Dossiers for CE marking, PMA applications, initial product reports and annual Reports for regulatory submissions.
- Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
- Reviews and recommends changes for design process and manufacturing procedures to maintain quality and regulatory compliance
- Key role in external audits related to product submission such as FDA, 3rd party external regulatory agencies like SFDA, KFDA, JPAL, etc. and notified body audits.
- Implements internal or external quality system audits.
- Provide leadership and guidance on global compliance, such as CE Marking per MDR and product registrations, clinical evaluations in accordance with MDD/MDR, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.
- Manage, mentor and coach multiple RA Managers in their development.
You are a part of
You are a part of Regulatory Affairs professionals based in Hamburg, Germany, Pune, India and Fitchburg, Wisconsin, USA. You will report to Head of Regulatory Affairs for Business Groups Diagnostic Imaging and Ultrasound. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience:
- Bachelor/Master of Science degree in a technical or business discipline.
- Minimum of 8-10 years of experience in a medical device company (FDA Class II and Class III and MDD/MDR).
- First line experience with FDA and MDD is required
- Management experience is required.
- Team player who can work in a matrix environment with employees in different locations
- International experience is a requirement
- Experience with CT Imaging systems is preferred
- Must have experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers and international documents or registration of medical device worldwide.
- Knowledgeable of ISO13485 and QSR requirements
- Excellent working knowledge of medical device regulations (21CFR), FDA law and CE marking
- Experience in supporting international registrations
- 15 to 20% travel to Israel and US.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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