Senior Regulatory Affairs Specialist
3 days ago
Job Title Senior Regulatory Affairs Specialist Job 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.
Minimum5 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
withcollaboration
to deliver great outcomes for our people andour customers.We areembracing an approach wherein wespend more time together than apart – which for
full-timeemployees
translates to an average of at least 3 daysworking from the office and up to 2 days from home – forour hybrid roles.
Hybrid work flexibility means people can meet the
changingdemands
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 ofimpactful collaboration: There's a certain energy when everyone’s in the same roomthat can heighten idea generation and creative frictionneeded for problem-solving.
Weembrace flexibility:
Choosing where, when, and how towork can vary according to task and team
schedules.Flexibilityisn’toffice
or online, it means choosing the spacethat works best for you, your teams, and our customers on acase-by-case basis.
We want tobe at our best:
The way
wework,and
ourworkspaces are designed to support our well-being, offercareer advancement opportunities, and enable us to be atour 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.
#J-18808-Ljbffr
-
Senior Regulatory Affairs Specialist
1 month ago
Plymouth, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Plymouth, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Plymouth, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
-
Regulatory Affairs Specialist II
1 month ago
Plymouth, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
-
Regulatory Affairs Specialist II
4 weeks ago
Plymouth, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
-
Manager, Regulatory Affairs
1 month ago
Plymouth Meeting, United States Braeburn Full timeReports to: Senior Director, Regulatory AffairsLocation: RemoteCompany Overview: Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a...
-
Manager, Regulatory Affairs
4 weeks ago
Plymouth Meeting, United States Braeburn Full timeReports to: Senior Director, Regulatory AffairsLocation: RemoteCompany Overview: Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a...
-
Manager, Regulatory Affairs
2 weeks ago
Plymouth Meeting, Pennsylvania, United States Braeburn Full timeReports to: Senior Director, Regulatory AffairsLocation: RemoteCompany Overview: Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a...
-
Plymouth, United States Interrad Medical Full timeThe Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is...
-
Plymouth, United States Interrad Medical Full timeThe Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is...
-
Plymouth, United States Interrad Medical Full timeThe Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is...
-
Plymouth, United States Interrad Medical Full timeThe Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is...
-
Plymouth, United States Baxter Full timeVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Plymouth, United States Baxter Full timeVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Associate Director, Regulatory Affairs
3 weeks ago
Plymouth Meeting, United States Organon & Company Full timeServe as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategi Regulatory Affairs, Chemistry, Director, Controls, Manufacturing, Regulatory, Technology, Healthcare
-
Manager, Medical Affairs Operations
2 weeks ago
Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full timeHarmony Biosciences is recruiting for a Manager, Medical Affairs Operations our Plymouth meeting, PA location. In this role you will be responsible for supporting the Medical Affairs Operations function through vendor management, budgeting, and project management for the department based on the Medical Affairs strategy. This role will prioritize and prepare...
-
Operations Specialist
1 month ago
Plymouth, United States Laurus Home Care Full timeJob DescriptionJob DescriptionRegional Operations Specialist - Independent LivingMichigan & OhioCompany paid Life InsuranceCompetitive Salary & Comprehensive benefitsGenerous PTO/HolidayOpportunity for Growth and DevelopmentPosition Summary - Regional Operations Specialist - Independent LivingThe Operations Specialist - is responsible to provide support,...
-
Associate Director, Regulatory Affairs
3 weeks ago
Plymouth Meeting, United States Organon Full timeJob Description The Position The Associate Principal Scientist is responsible fordeveloping andimplementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies forassignedsmall molecule products in accordance with global regulations andguidance's, andCompany procedures. The Associate Principal Scientist will lead thepreparation and submission...
-
Manager, Medical Affairs Operations
1 month ago
Plymouth Meeting, United States Harmony Biosciences LLC Full timeHarmony Biosciences is recruiting for a Manager, Medical Affairs Operations our Plymouth meeting, PA location. In this role you will be responsible for supporting the Medical Affairs Operations function through vendor management, budgeting, and project management for the department based on the Medical Affairs strategy. This role will prioritize and prepare...
-
Manager, Medical Affairs Operations
3 weeks ago
Plymouth Meeting, United States Harmony Biosciences LLC Full timeHarmony Biosciences is recruiting for a Manager, Medical Affairs Operations our Plymouth meeting, PA location. In this role you will be responsible for supporting the Medical Affairs Operations function through vendor management, budgeting, and project management for the department based on the Medical Affairs strategy. This role will prioritize and prepare...
