"Alerted.org

Regulatory Affairs Business Specialist

In this role, you will support regulatory compliance and business objectives for our Image-Guided Therapy Devices business by coordinating regulatory activities and ensuring products meet relevant medical device standards and requirements.

Your role:

+ Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional teams to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.

+ Demonstrates basic understanding of Regulatory's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.

+ Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.

+ Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.

+ Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related change control processes, supporting the Marketing Teams on Tender related issues.

+ Participates in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the Business and Field levels.

+ Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.

You're the right fit if:

+ Experience in regulatory affairs, quality compliance, product development or equivalent in the medical device industry strongly preferred.

+ Your skills include knowledge and experience working relevant medical device regulations and standards. Experience with Rimsys, SAP, and/or Windchill preferred.

+ You have a bachelor’s degree or higher in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent required. RAPS RAC certification preferred but not required.

+ You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

+ You’re an excellent communicator (written and verbal) with an ability to manage and prioritize multiple deliverables based on urgency.

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-based 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 (https://www.philips.com/a-w/about.html) **.**

+ **Discover** our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)

+ **Learn more about** our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)

+ **Learn more about** our culture. (https://www.careers.philips.com/na/en/our-culture-philips-careers)

Philips Transparency Details

The pay range for this position in Colorado Springs, CO is $60,750 to $97,200.

The pay range for this position in Plymouth, MN is $63,788 to $102,060.

The pay range for this position in San Diego, CA is $68,040 to $108,864.

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 (https://www.philipsusbenefits.com/) .

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 Colorado Springs, CO, Plymouth, MN, or San Diego, CA.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran