We are fundamentally altering the cancer treatment landscape by creating a modality that uses the unique biology of each tumor as a means to destroy it. Our ground-breaking approach marries positron emission tomography (PET) – the gold standard for visualizing cancer – with radiotherapy – one of the most effective ways to treat cancer. This combination, biology guiding radiotherapy (BgRT), turns cancer on itself, and finally enables radiotherapy for all stages of cancer, including metastatic disease. Biology guiding radiotherapy offers hope for millions of patients who today, have limited treatment options.
At the center of our bold vision, are passionate, committed team members who align with our culture:
- Bold. We aren’t here to fit in and provide yet another radiotherapy solution; we’re here to change the game.
- Confident. We don’t shy away from the challenge of implementing a breakthrough in cancer care – we tackle it head on from all dimensions.
- Heart. Fueled by our own experiences with cancer, this is personal. It’s driven us to develop solutions that have, until now, seemed impossible.
- Challengers of convention. We don’t let today’s technology be a barrier. We dream big and innovate to make our dreams a reality.
The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory, and business issues to enable products that are developed to meet regulatory requirements. The individual may identify information needed, obtain data and ensure that the information is effectively presented for the registration of products worldwide.
The Senior Regulatory Affairs Specialist should also have sufficient experience in regulatory compliance to provide direction and guidance to R&D, manufacturing, and marketing/sales regarding changing regulatory requirements and standards.
This position reports to the VP of Regulatory, Quality Assurance and Clinical Affairs.
Essential Duties / Responsibilities (Other duties may be assigned)
- Assist in writing and preparing regulatory submissions and filings required for U.S. FDA and other regulatory bodies (e.g. Notified Bodies for CE marking, Health Canada Licenses, etc.) as needed
- Evaluate changes to products for impact on global regulatory approvals.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Support product development teams with regards to implementation of international regulatory requirements.
- Oversee processes involved with maintaining annual licenses, registrations, listings
- Work with management to ensure compliance with product post marketing approval requirements
- Work with the internal team for assessment of product reporting/recall activities
- Work with the appropriate internal groups to report adverse events to regulatory agencies and internal stakeholders
- Maintain and update regulatory affairs procedures and changes
- Help with continuous improvement of the submission process
Qualifications / Skills Required
- Bachelor’s degree in a scientific discipline; advanced degree preferred; RAC (Regulatory Affairs Certificate) a plus
- Five or more years’ experience in medical device regulatory affairs with direct project management responsibilities
- Experience in assisting the development, writing and submittal of successful 510(k)/PMA/De Novo submissions
- Must have prior working experience with application processes for 510(k)s, Health Canada Applications and CE Mark applications and technical files
- Working knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820.
- Knowledge of software development as it relates to regulatory submissions a plus
- Knowledge of electromechanical medical devices, or complex software-driven medical devices is required
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Excellent oral and written communication skills
- Excellent attention to detail
- Excellent organizational and negotiation skills
- Ability to work independently as an individual contributor and in a team environment
- Requires ability to work on-site for position in Hayward, CA