Regulatory Affairs Specialist (Freelance)

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.