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Regulatory Affairs Specialist
4 months ago
Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
In this role you have the opportunity to
Position is needed to support the needs of the IGTD CV organization. Initial specific efforts include but are not limited to: (1) US FDA catchup submissions and remediation (e-technical document). (2) Support CAPAs and related time-sensitive compliance efforts for Regulatory department. (3) Support international regulatory team on efforts to achieve global submissions goals in FY'24 and beyond.
Responsible for authoring and maintaining US and EU regulatory submissions for new product development and sustaining projects specific to the Image Guided Therapy Devices (IGTD), Coronary Vascular (CV) portfolio. This position also supports the IGTD international regulatory teams, compliance efforts, and department operations.
Your role:
With supervision from more senior level colleagues, a Regulatory Affairs Specialist is responsible for:
- Preparing global regulatory strategies for new product development. Identifying risks within the strategies and determining ways to mitigate those risks.
- Preparing regulatory submissions (e.g., US 510(k), US Q-Sub, EU CE Technical Document) for new or modified products.
- Supporting design, manufacturing, and labeling changes by evaluating the impact to domestic and international submissions, communicating the impact to the team, and taking required regulatory action.
- Investigating issues under corrective and preventive actions (CAPA), determining root cause, and working with others to develop solutions to resolve problems.
- Based on knowledge of standards and regulation, providing regulatory recommendations, decisions, and feedback to product development and manufacturing teams, as needed.
- Following Quality System procedures to ensure compliance with US 21 CFR 820, ISO 13485, MDD/MDR, CMDR, MDSAP.
- Supporting regulatory department on various operations efforts to increase and maintain efficiency and compliance.
You're the right fit if:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- BS degree in regulatory, engineering, or scientific discipline. MS degree preferred
- 1+ years of medical device experience or equivalent by education (regulatory field).
- Strong oral and writing skills. Good communication. Attention to detail.
- Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
- Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and other for results.
- Is personally committed to and actively works on continuously improve him/herself; understands that different situations and levels my call for different skills and approaches; works to deploy strengths; works on compensating for weakness and limits.
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 $52,000,000 to $97,000, 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.
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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.
