Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialist remote type:
Office Based locations:
AUS S:
SRV LEtime type:
Full time posted on:
Posted 11 Days Agojob requisition :
R-24182

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

The Senior Regulatory Affairs Specialist is an individual contributor who works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Varian Medical Systems, Inc. (a Siemens Healthineers Company), specifically within the Interventional Oncology business.
This role combines knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed in compliance with global regulatory requirements. Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and provides critical regulatory support for new product development. This is an on-site role in the Austin, Texas or Shoreview, Minnesota office with less than 20% travel requirements.#

Key Responsibilities:

* Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units.
* Outline submission and clearance requirements in assigned geographies.
* Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes.
* Effectively collaborate with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
* Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
* Compile, prepare, review, and submit high-quality regulatory submissions to authorities on time in US, EU, and Canada; support international regulatory team with submissions to other geographies as required.
* Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals.
* Effectively communicate internally with cross-functional teams and externally with regulatory agencies.
* Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements.
* Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.
* Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
* Provide regulatory input for product recalls and recall communications.
* Support quality system and technical file/design dossier audits.
* Maintain regulatory files and tracking databases as required.
* Evaluate import/export requirements.
* Identify emerging issues and provide guidance to functional groups.
* Exercise good and ethical judgment within policy and regulations.
* Perform multiple tasks concurrently with accuracy.
* Provide guidance to functional groups in the development of relevant data for regulatory submissions.
* Support internal and external audits# Qualifications
** Regulatory Role Specific:
*** 5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices.
* Must have experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.
* Experience in the use of clinical data to support regulatory submissions (e.g. expansion of indications)
* Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.
* Ability to follow…