Regulatory Affairs Manager
Regulatory Affairs Manager
In this role, you have the opportunity to
Leads business unit regulatory resources and shares the workload (hands on) to ensure timely product registrations, regulatory planning for new product introductions (ventilators and related devices/accessories) and product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.
You are responsible for
- This position is responsible for managing the HRC (Hospital Respiratory Care) regulatory team (Carlsbad, CA, Wallingford, CT and Monroeville, PA).
- Drives the message that we need to provide "quality" products which are safe and effective.
- Responsible for product registrations/approvals.
- Responsible for working with HRC Q&R Business Leader to prepare for compliance with new EU MDR (Medical Device Regulation).
- Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
- Recommend and develop strategies and create detailed written regulatory plans for:
- IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
- Traditional, abbreviated, special 510(k)s or PMAs.
- FDA presubmission meetings
- Worldwide product registrations
- Responsible for the coordination and preparation of document packages 510(k) pre-market notification, PMAs, technical file and design dossiers for CE marking, China CFDA domestic registrations and support worldwide product registrations per in-country regulations
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
- Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, EU MDR (moving forward), ISO 13485, Canadian CMDCAS, US FDA's and China CFDA's guidance documents & etc.
- May represent Philips in an international committee chartered to develop an applicable standard.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Coordinate testing required to support regulatory submissions.
You are a part of
Our Hospital Respiratory Care (HRC) solutions are helping caregivers and lay responders both inside and outside the hospital. We are the number one provider of therapeutic care solutions, saving and improving more and more lives every year.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree (Master's preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- Experience with ventilators strongly preferred.
- Minimum of 8 years of experience in the medical device industry (EU MDD, US FDA class II, class III)
- Must have personal "hands on" experience with successful preparation, submission and clearance of five or more 510(k)s. Regulatory & technical competency is also expected with CE marking / technical files and PMA experience is strongly preferred.
- Experience in supporting international registrations, clinical investigations and clinical evaluation reports.
- RAPs RAC preferred.
- Strong background in Design Controls.
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD/EU MDR, MDSAP and other global laws and regulations and standards.
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require limited travel annually.
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
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. Learn more by watching this video.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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