Regulatory Affairs Program Manager

25 Apr, 2021

Jobs

Regulatory Affairs Program Manager

Phillips
Bothell, WA

Job Title

Regulatory Affairs Program Manager

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

This position will focus on managing regulatory workflows to ensure proper resourcing of projects and work with cross functional teams to drive regulatory deliverables within overall projects

You are responsible for

  • Provides guidance on risk assessment, and required corrective actions to meet regulatory requirements
  • Assesses regulatory standard (e.g. ISO, IEC, AAMI) impact to business operations and product development
  • Works on issues where analysis of situations or data requires an in-depth knowledge of regulations, design controls, risk assessment processes, and organizational objectives.
  • Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
  • Regularly interacts with management and cross-functional teams to provide regulatory strategy at all stages of a products lifecycle.
  • Mentors junior regulatory affairs members in their development.
  • Responsible for product registrations/approvals.
  • Recommend and develop strategies and create detailed written regulatory plans for:
    • IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
    • Pre-market Approval (PMA) Applications
    • Pre-submission applications
    • Worldwide product registrations
  • Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
  • Provide audit and CAPA support
  • Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, EU MDR, compliance with FDA’s guidance documents etc.
  • Responsible for ensuring compliance with the current PCMS regulatory procedures and updating the procedures when new regulatory requirements become effective.
  • 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.
  • Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
  • Responsible for the coordination and preparation of document packages 510(k) pre-market notification and PMA applications, technical file and design dossiers for CE marking, and worldwide product registrations.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • May represent Philips in an international committee chartered to develop an applicable standard.
  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
  • Coordinate testing required to support regulatory submissions.

You are a part of

The Philips Emergency Care and Resuscitation business products include hospital Automated External Defibrillators (AED)/Monitoring equipment and portable Emergency Services/Public Access and Home AEDs.  Our devices are able to automatically detect and recognize shockable heart rhythms in victims of sudden cardiac arrest.   These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree (Master’s or Ph.D. preferred) preferably in Regulatory Affairs, Engineering, and/or the life sciences, or equivalent experience in the medical device industry.
  • RAPS RAC strongly preferred. ASQ certifications also desirable.
  • 5+ years of experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II and class III, etc.).
  • Experience with software products preferred.
  • Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
  • Strong background in Design Controls.
  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
  • Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
  • Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
  • Experience in supporting international registrations and/or clinical investigations.
  • May require 5% travel annually with possibly some international.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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

Job Title

Regulatory Affairs Program Manager

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

This position will focus on managing regulatory workflows to ensure proper resourcing of projects and work with cross functional teams to drive regulatory deliverables within overall projects

You are responsible for

  • Provides guidance on risk assessment, and required corrective actions to meet regulatory requirements
  • Assesses regulatory standard (e.g. ISO, IEC, AAMI) impact to business operations and product development
  • Works on issues where analysis of situations or data requires an in-depth knowledge of regulations, design controls, risk assessment processes, and organizational objectives.
  • Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
  • Regularly interacts with management and cross-functional teams to provide regulatory strategy at all stages of a products lifecycle.
  • Mentors junior regulatory affairs members in their development.
  • Responsible for product registrations/approvals.
  • Recommend and develop strategies and create detailed written regulatory plans for:
    • IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
    • Pre-market Approval (PMA) Applications
    • Pre-submission applications
    • Worldwide product registrations
  • Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
  • Provide audit and CAPA support
  • Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, EU MDR, compliance with FDA’s guidance documents etc.
  • Responsible for ensuring compliance with the current PCMS regulatory procedures and updating the procedures when new regulatory requirements become effective.
  • 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.
  • Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
  • Responsible for the coordination and preparation of document packages 510(k) pre-market notification and PMA applications, technical file and design dossiers for CE marking, and worldwide product registrations.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • May represent Philips in an international committee chartered to develop an applicable standard.
  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
  • Coordinate testing required to support regulatory submissions.

You are a part of

The Philips Emergency Care and Resuscitation business products include hospital Automated External Defibrillators (AED)/Monitoring equipment and portable Emergency Services/Public Access and Home AEDs.  Our devices are able to automatically detect and recognize shockable heart rhythms in victims of sudden cardiac arrest.   These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree (Master’s or Ph.D. preferred) preferably in Regulatory Affairs, Engineering, and/or the life sciences, or equivalent experience in the medical device industry.
  • RAPS RAC strongly preferred. ASQ certifications also desirable.
  • 5+ years of experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II and class III, etc.).
  • Experience with software products preferred.
  • Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
  • Strong background in Design Controls.
  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
  • Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
  • Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
  • Experience in supporting international registrations and/or clinical investigations.
  • May require 5% travel annually with possibly some international.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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

Learn more here

Job posted: 2021-04-25