JOB DESCRIPTION
Job Title Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist (U.S. Hub based location) The Senior Regulatory Affairs Specialist is responsible for regulatory compliance, strategy and submissions related to accessory devices/products (mixture of class 1 and class 2). The Senior Regulatory Affairs Specialist will leverage their industry knowledge to guide regulatory strategies efficiently.
Your role: Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products. Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy Responsible for regulatory planning for new product introductions (NPI) and product changes, and ensuring maintenance of global regulatory compliance. Responsible for product registration submissions/approvals as well as license renewals and updates for EU and further worldwide locations. Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed. Continuously analyze US, EU, and international regulatory requirements and initiate relevant design changes. Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements. Analyze and optimize RA processes together with cross-functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs, etc. in order to improve procedures or integrate new and changing standards and regulations. Provide regulatory support for Audit, IIA, Post-Market/Clinical and CAPA. Ensure standard and process compliance is met. Mentor other regulatory affairs personnel within the team. You're the right fit if: You've acquired 4+ years of experience in regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.). Experience with FDA 510(k) submissions required. Your skills include strong communication skills (written and verbal), and proficient knowledge of domestic and international standard; ability to multitask and perform with accuracy and a high attention to detail. Understanding of lean/kaizen concepts and methodologies preferred. You have a bachelor's degree or equivalent internationally acquired qualification preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry. RAPS RAC strongly preferred. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. You're an excellent communicator, who is solution and detail-oriented. You are well organized and self-motivated with a willingness towards self-improvement opportunities. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business . Discover our rich and exciting history. Learn more about our purpose. Read more about our employee benefits . If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .
Philips Transparency Details The pay range for this position is $74,000 to $136,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations . #LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
