Regulatory Affairs Specialist (Entry Level)

Philips • Cambridge, MA

3d • $60,750 - $100,000 • Onsite

About The Position

Regulatory Affairs Specialist
In this role you
Be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy.
Your role:
Assist in the implementation of comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects
Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards
Help maintain processes for regulatory filings/ licenses and developing technical contribution by collaborating with central and regional Regulatory Affairs teams
Participate in evaluating product development quality reports and support submissions, coordinate and prepare regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but typically not complex
Perform Change Management activities including hosting meetings to acquire change details for sustaining products in the market, notify geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance, reducing overall regulatory burden while ensuring full compliance
You're the right fit if:
Bachelor’s degree or equivalent qualification preferably in Regulatory Affairs and/or a science related field. Prefer 2+ years of experience in Regulatory Affairs in Medical Device
The ability to work cross functionally in a multinational organization
Strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and a high attention to detail.
Excellent personal and intercultural skills that include being solution and detailed-oriented, well organized, self-motivated, team player, and a willingness and openness for self-improvement
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 Cambridge, MA is $60,750 to $100,000 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 Cambridge, MA.
#LI-PHI
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.

Requirements

• Bachelor’s degree or equivalent qualification preferably in Regulatory Affairs and/or a science related field.
• The ability to work cross functionally in a multinational organization
• Strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and a high attention to detail.
• Excellent personal and intercultural skills that include being solution and detailed-oriented, well organized, self-motivated, team player, and a willingness and openness for self-improvement
• 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.

Nice To Haves

• Prefer 2+ years of experience in Regulatory Affairs in Medical Device

Responsibilities

• Assist in the implementation of comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects
• Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards
• Help maintain processes for regulatory filings/ licenses and developing technical contribution by collaborating with central and regional Regulatory Affairs teams
• Participate in evaluating product development quality reports and support submissions, coordinate and prepare regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but typically not complex
• Perform Change Management activities including hosting meetings to acquire change details for sustaining products in the market, notify geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance, reducing overall regulatory burden while ensuring full compliance

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees