Senior Regulatory Affairs Manager (Freelance)
Actively contribute in the development and implementation of regulatory strategies for product development and approval (New Product Introduction). You are responsible for specific regulatory documents preparation, review and submission, and assist with compliance issues. You provide regulatory support to other departments, project teams, and committees in managing the development of medical device products for Mother & Childcare
You are responsible for
- Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (including prepare, coordinate and review multiple submissions and projects effectively. Ensure consistency, completeness and adherence to standards for all regulatory submissions.
- Participate in the study management & regulatory submission teams
- Execute, with appropriate guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
- Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees; etc.)
- Direct interaction with regulatory agencies on defined matters on global level. Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
- Provide regulatory guidance and train peers
You are a part of
A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the RA-SCR Leader, Mother& Childcare, with Cross functional team as your key stakeholders.
The Philips business group Personal Health delivers innovative lifestyle solutions for personal well-being. Our brand promise delivers innovation that matters to you, meaning that our products are caring, innovative & impactful. The sector builds on a deep understanding of people's needs and aspirations to create innovations that help consumers achieve their lifestyle ambitions.
The position is part of one of the key growth areas in Personal Health being the Mother and Child Care category. You will be based out of Eindhoven, the Netherlands
To succeed in this role, you should have the following skills and experience
- Master's degree with a minimum of 8 years of experience in regulatory affairs
- At least 5 years of experience in medical device company managing regulatory submission processes with global authorities (EU, Brazil, US, Canada).
- Must have experience with successful preparation and submission of 510 (k), pre-submissions, and all supportive amendments or supplements
- Excellent working knowledge of medical device regulationsISO 13485, FDA Law (21CFR 820), MDD, other global laws and regulations
- Experience in supporting international registrations and clinical investigations
- Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
- Ability to work either independently with minimal direction separately or within project teams, committees, etc. to attain group goals
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills