Regulatory Affairs Manager

Summary of the Assignment
The Regulatory Affairs Manager is responsible and accountable for providing hands-on and valued regulatory guidance, strategy (verbal and written), and oversight to the PHM VitalHealth Business. The PHM VitalHealth Regulatory Manager shares the workload across PHM Regulatory and Clinical Affairs and has the following Key Areas of Responsibilities:

Your challenge
Do you want to accelerate innovation and the creation of new healthcare products that matter?
Do you believe that healthcare needs to be revolutionized and that a combination of connected consumer propositions and medical devices will drive that revolution?
Do you want to help define the future of healthcare by developing first-of-a-kind solutions that have a positive impact on people’s health?

Your responsibilities
As a Regulatory Affairs Manager you are responsible for:
•   Advising on regulatory approval, regulatory compliance, and quality management related topics.
•   Establishing operational objectives and project plans and works within the terms of budgets, schedules, and appropriate processes.
•   Providing guidance and advises internal stakeholders (including but not limited to: marketing, manufacturing, R&D, etc.) regarding current/pending regulatory guidance, regulations, standards, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
•   Developing, approving, implementing, and managing the regulatory strategy that supports PHM propositions throughout their product lifecycle.
•   Updating and maintaining regulatory documents and records, databases, and maintains organized record keeping.
•   Technical file/DHF compilations and compliance.
•   Communicating directly with Regulatory Authorities/Notified Bodies/Competent Authorities and addresses requests for information (i.e. FDA pre-submission meetings, 513(g), CE-Mark, etc.).
•   Creating detailed written regulatory plans that will be used to target domestic and international product approvals, registrations, and/or certifications (i.e. Traditional, abbreviated, special 510(k)s, CE-Mark, and Worldwide product registrations).
•   Aligning and implementing effective regulatory solutions for Philips business products/devices/accessories and services.
•   Developing effective remediation strategies (when applicable) to ensure regulatory compliance for applicable Philips business products/devices/accessories and services.
•   Developing, preparing, and submitting regulatory submissions for product registration for the USA, Canada, EU and other worldwide locations (as identified and applicable) in collaboration with worldwide colleagues in the markets.
•   Coordination, preparation and submission of document packages 510(k) pre-market notification, technical file and design dossiers for CE marking, and supports worldwide product registrations per in-country regulations.
•   Reviewing and approving new product introductions and engineering changes.
•   Reviewing and approving advertising, promotional items, marketing communications, and product labeling for regulatory compliance.
•   Identifying potential regulatory approval risks based on changes in regulations, standards, country specific issues, or other unique characteristics of projects.
•   Keeping current with regulatory guidance and requirements in the global environment.
•   Working with quality department to prepare for compliance with new EU MDR (Medical Device Regulation).
•   Supporting the implementation of regulatory based procedures in accordance to the QMS.
•   Developing, updating, and implementing regulatory policies and procedures in alignment with Philips PEPF.
•   Communicating regulatory status/progress to internal stakeholders and occasionally interacts with senior management or executive levels on matters concerning several functional areas and/or customers.
•   Supporting post-market surveillance activities.
•   Developing talent and build up Regulatory as a value–added business partner
•   Strengthening and build regulatory capabilities.

Our offer
We offer the opportunity to play a leading role in achieving Philips’ ambitions with digital connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with colleagues from the Electronics department as well as other Software departments across Philips, playing a key role in driving the transition process that will turn Philips into a Digital Systems company. We invite you to be part of a challenging, innovative environment with great opportunities for personal development.

We are looking for someone
•   who is proactive, vigorous, and self-propelling
•   who has:
•   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 Software as a Medical Device (SaMD) strongly preferred.
•   7+ 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 with CE marking / technical files.
•   Experience in supporting international registrations
•   RAPs RAC preferred.
•   Strong background in Design Controls.
•   Proficient knowledge of medical device regulations (21CFR), FDA, MDD/EU MDR, MDSAP and other global laws, regulations and standards.
•   Proficient computer skills in Microsoft Office.
•   Understand LEAN concepts, methodologies and deployment.
•   May require limited travel annually.
•   Profound knowledge of Android
•   Good Java programming skills
•   Proven track record of object oriented analysis and design
•   
This role will appeal to you if you ….
•   Enjoy working in cross-functional teams
•   Are curious, open and feel at home in a dynamic environment
•   Have an affinity with innovative development projects and feel comfortable with relatively vague requirements