With the exception of independent contractors, applicants for this role will be engaged through Randstad company. When making this application your details will be automatically shared with Randstad company for registration with them, who may also contact you about other opportunities with other clients.

Philips

Regulatory Affairs Specialist (Freelance)

Posted Jul 13, 2021
Project ID: PHILJP00023602
Location
Ede
Duration
6 months
(Aug 2, 2021 - Feb 1, 2022)
Hours/week
40 hrs/week
Payrate range
48 - 71 €/hr

Be responsible for implementing and supporting the global regulatory strategy and roadmaps through understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy within VitalHealth and Population Health Management (PHM).


You are responsible for:

-   Providing leadership and project management for regulatory deliverables as directed by manager.

-   Regulatory planning for new product introductions and product updates.

-   Advising product design teams on regulatory strategy and requirements for updated and/or new products.

-   Being involved in developing, modifying and executing company regulatory policies that affect immediate operations.

-   Interacting with senior management on matters concerning several functional areas and/or customers.

-   Facilitating communication and leveraging of best practices as applicable.


Key Areas of Responsibility (KARs):

-   Establish and provide tactical alignment across VitalHealth on regulatory aspects of:

-   State of the Art - standards- implementation.

-   Audit support and follow-up (includes Notified Body, FDA, MDSAP and unannounced audits/inspections).

-   UDI support and follow-up.

-   Facilitate updates to:

-   Medical device license renewals and establishment registrations for applicable countries.

-   MDD/EU MDR/MDSAP certificates of registration and scope statements.

-   510(k) Tracking Database and similar tools.

-   CE Marked Medical Devices' List.

-    ROW renewals and registrations as directed.

-   Provide technical competency and guidance to the business group regarding:

-   Implementation of the new EU MDR which will replace the MDD.

-   PHM direction towards one QMS.

-   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.

-   Write/submit regulatory applications as directed (EU, FDA, ROW, etc.).

-   Support development of the Regulatory Plan, provide guidance on risk assessments and CAPA to meet regulatory requirements such as CE Marking.

-   Develop and facilitates regulatory submissions for new products/solutions and product updates.

-   Review marketing and labelling materials for regulatory compliance.

-   Drive improvement in regulatory aspects of the QMS by developing/updating processes to ensure and maintain quality and regulatory compliance.

-   Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.

-   Update regulatory procedures when new regulatory requirements become effective.

-   Assist the regulatory leadership to strengthen and build VitalHealth regulatory capabilities.

-   Often must lead a cooperative effort among members of a project team.

-   Maintain regulatory files and tracking databases as required.

-   Ensure that training assignments remain current.


You are a part of

As a regulatory specialist, you are part of a motivated and self-propelled European team in VitalHealth which is part of a global regulatory team in PHM. You will work closely with other business areas including quality assurance, privacy and security in a fast-paced dynamic software environment. You will liaison with the US regulatory team.


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

-   Bachelor's degree preferably in Regulatory Affairs and/or a science related field

-   3-5 years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA, etc.)

-   Proficient knowledge of domestic and international standards. Experience with Software as a Medical Device (SaMD) is preferred - not required

-   Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.

-   Experience in Design Controls would be preferred

-   Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.

-   Familiarity of medical device regulations (EU MDR, 21CFR/FDA, etc.) and other global laws, regulations and standards including ISO 13485, ISO 14971 and other related regulatory and quality standards.

-   May require some travel. Also to site Ede.

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