Senior Regulatory Affairs Specialist - Medical Devices

Senior Regulatory Affairs Specialist

Job Title

Senior Regulatory Affairs Specialist

Job Description

Senior Regulatory Affairs Specialist

In this role you

The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.  This may include ventilators, oxygenators, and other accessories.  The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management.

Your role:

• The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW
• Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.
• Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.
• Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published.
• Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities.

You're the right fit if:

• Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.

• 10+ years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR 2+ years' experience with Master's Degree
• Experience with Regulatory Requirements - 21 CFR 820, EU MDR, ISO 13485, Regulatory Standards, Regulatory Submission Documentation - 510k, Health Canada licenses, EU MDR Technical Documentations, Product Registrations - US, EU, Canada, Product Labeling - US, EU, Canada

• Preferred Skills: Regulatory Requirements,Quality Management Systems (QMS),Troubleshooting,KPI Monitoring and Reporting,Data Analysis & Interpretation,Process Improvements
• 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. 

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

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.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Murrysville, PA is $100,040 to $127,400 Annually. 

The pay range for this position in Cambridge, MA is $109,100 to $135,000 Annually. 

The actual base pay offered may vary within the posted ranges 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 Murrysville, PA or Cambridge, MA.

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Experience Level

Senior Level