Regulatory Affairs Specialist

Job Title

Job Description

The Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development design and manufacturing changes and sustaining activities for high risk surgically invasive image guided therapeutic devices.

Your role:

• Authors regulatory submissions for US EU and Canada for all classes of medical devices including 510(k)s PMA supplements EU MDR Technical Documents and pre-submissions.
• Takes ownership of regulatory planning for new product introductions and product changes assisting in the maintenance of regulatory compliance throughout the product lifecycle.
• Supports product sustaining activity for all classes of medical devices including product defect assessments issue impact assessments health hazard evaluations corrections and removals and CAPAs as a regulatory SME.
• Reviews labeling marketing materials and claims substantiation evidence to maintain compliance with global requirements.
• Monitors and handles potential regulatory impacts on product safety implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks.
• Demonstrates substantial understanding of regulators role in the Quality System with good awareness of product lines disease states and customers possessing general knowledge of business developed through education or prior experience.

Youre the right fit if:

• Youve acquired a minimum of 3 years experience in Regulatory Affairs within FDA and/or EU MDR regulated Medical Device environments.
• Your skills include experience with 510(k)s PMA supplements EU MDR Technical Documents and pre-submissions.
• You have familiarity with FDA EU MDR Health Canada and other relevant international regulatory standards regulations and submission paths.
• You have a minimum of a Bachelors Degree (Required). Degree in a scientific discipline preferred.
• You have the proven ability to build strong relationships with internal and external stakeholders at all levels sharing knowledge providing regulatory insights and ensuring alignment with regulatory requirements.
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations. This is an Office-Based role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality of 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 Colorado Springs CO is $87000 to $139200

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.

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.

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 this position you must reside in or within commuting distance to Colorado Springs CO
• May travel up to 10%

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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 including Disability/Vets and maintains a drug-free workplace.