This is a role well suited to an ambitious professional, looking for the next step in their career. This is a remote role.
As a Senior Regulatory Affairs Specialist, you will be responsible to:
- Prepare, submit, and maintain regulatory submissions and lifecycle documentation,including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
- Serve as a Regulatory Affairs subject matter expert, providing guidance to design controlactivities and new product development teams.
- Prepare, submit, and maintain Technical Files in compliance with applicable regulatoryrequirements and the Quality Management System (QMS).
- Collaborate with cross‑functional teams to develop and maintain quality guidelines,procedures, and work instructions that support ongoing regulatory compliance.
- Independently or collaboratively lead and contribute to regulatory projects, ensuring timelyexecution and alignment with regulatory strategy.
- Provide training to internal stakeholders on country‑specific regulatory requirements, as applicable.
- Independently or as part of a team, review promotional and labeling materials for regulatorycompliance in accordance with country‑specific requirements.
- Ensure audit‑ and inspection‑ready documentation and provide guidance tocross‑functional teams on appropriate regulatory documentation practices.
- Participate in internal and external audits, including quality system audits, design dossierreviews, and regulatory authority inspections, as applicable.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:
- Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance Knowledge of point-of-care IVD products and applicable regulations for such products
- You have very good presentation skills, and you show team orientation and communication skills.
- Ensure cross-functional collaboration and cooperation.
- Excellent attention to details.
- Able to multi-task and work effectively in a dynamic environment.
- Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
Required skills to have for the success of this role:
- Bachelor’s degree in scientific discipline
- Minimum of 4 years of experience in IVDs or Medical devices
- Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps
- Experience of working in a GMP environment
- Intercultural sensitivity
- Strong attention to detail and excellent organizational skills
The base pay range for this position is:
$117,770 - $161,931
Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
