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.