Regulatory Affairs Specialist; Entry Level

Regulatory Affairs Specialist (Entry Level)

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You will 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.

• 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.
• Assist in coordinating and developing conformity assessment strategies and plans that support regulatory submissions, ensuring alignment with regulatory requirements and standards.
• Help maintain processes for regulatory filings/licenses and develop technical contributions 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, identifying, defining and addressing 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, and reduce overall regulatory burden while ensuring full compliance.

• Bachelor’s degree or equivalent in Regulatory Affairs and/or a science‑related field;
  Prefer 2+ years of experience in Regulatory Affairs in Medical Devices.
• Ability to work cross‑functionally in a multinational organization.
• Strong written, oral and interpersonal skills to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and high attention to detail.
• Excellent personal and intercultural skills, including being solution‑oriented, detail‑oriented, well‑organized, self‑motivated, team player, and open to self‑improvement.
• Physical, cognitive and environmental job requirements that can be accommodated for this office/remote position.

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. This is an office role.

We are a health technology company built on the belief that every human matters. We strive to provide quality healthcare to all. If you want to help improve the lives of others, this role is for you.

The pay range for this position in Cambridge, MA is $60,750 to $100,000 annually. Compensation may vary based on factors such as job‑related knowledge, skills, experience, business needs, location, and internal equity. Additional compensation, such as an annual incentive bonus, sales commission, or long‑term incentives, may be offered. Employees are eligible for our comprehensive total rewards program, which includes generous PTO, 401(k) (up to 7% match), HSA with company contribution, stock purchase plan, education reimbursement, and more.

U.S. 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; you must reside in or be within commuting distance to Cambridge, MA. This requisition is expected to remain active for 45 days, but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.