Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
In this role, you have the opportunity to
Formulate the medium term regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations.
You are responsible for
• Leads business unit regulatory resources and shares the workload (hands on) to ensure timely product registrations, regulatory planning for new product introductions and product changes.
• Provide 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.
• Establishes operational objectives and work plans, and delegates assignments to subordinates.
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas and/or customers.
• Responsible for product registrations/approvals.
• Responsible for working with Q&R Business Leader to prepare for compliance with new EU MDR (Medical Device Regulation).
• Keep abreast of current regulatory procedures and changes.
• Recommend and develop strategies and create detailed written regulatory plans
• Responsible for the coordination and preparation of document packages 510(k) pre-market notification, technical file and design dossiers for CE marking, China (NMPA) 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
• Responsible for ensuring compliance with regulatory procedures and updating the procedures when new regulatory requirements become effective.
• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
• Review and approve advertising, promotional items and labeling for regulatory compliance.
• Maintain regulatory files and tracking databases as required.
To succeed in this role, you should have the following skills and experience
• Bachelor's degree (Master's or PhD preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
• Minimum of 8 years of experience in the medical device industry (EU MDD, US FDA class II, class III) or 12 years of regulatory experience if the candidate's background does not include class III devices.
• Extensive experience preparing and submitting software 510(k)s.
• Familiarity with Artificial Intelligence (AI) products and regulatory submissions
• Experience with sterile product registrations
• Solid understanding of Unique Device Identifier UDI) requirements.
• Must have personal "hands on" experience with successful preparation, submission and clearance of 510(k)s. Regulatory & technical competency also expected with CE marking / technical files 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.
• Understand LEAN concepts, methodologies and deployment.
• May require limited travel annually.
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
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.
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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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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