Senior Regulatory Affairs Specialist

4 weeks ago

Brockton, Massachusetts, United States Philips Full time
Job TitleSenior Regulatory Affairs SpecialistJob Description

Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

In this role you have the opportunity to

You will prepare comprehensive regulatory strategies and filings for both new and legacy devices including significant device changes. You will clearly communicate strategies to RA management, core teams, and business unit leadership for device change activity. You will design, build, implement, and sustain world-class regulatory affairs recommendations, decisions, and submissions while employing working knowledge of global regulatory requirements.

Your role:

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Create comprehensive regulatory strategies.
  • Develop and prepare product registration submissions for the US, Canada, EU and support worldwide international submissions as assigned.
  • Review and approve advertising, promotional items and labeling for regulatory compliance.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders.
  • Collaborate with worldwide colleagues regarding license renewals and updates.
  • Communicate with regulatory agencies as needed.
  • Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc.
  • Provide audit, CAPA and post market regulatory support as assigned.

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

  • Bachelor's degree or Master's degree in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
  • Minimum 5 years of regulatory approvals and submittal experience (EU MDR, Health Canada, USA (PMA, 510k).
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
  • Proficient knowledge of domestic and international standards.
  • Regulatory Affairs Professionals RAC strongly preferred.
  • Understand LEAN concepts, methodologies and deployment.

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.
  • Read more about our employee benefits.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $77,000,000 to $136,000, Annually. The actual base pay offered may vary 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.

How we work at Philips

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.​

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:​

We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.

​

We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. ​

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.

#LI-PHI

#LI-HYBRID

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/Disabled/Veteran and maintains a drug-free workplace.

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