Senior Regulatory Affairs Specialist

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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, ensures 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. This role will not support Visa sponsorship or Visa transfer.

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 scientific arguments, identify regulatory scientific data needs, and solve regulatory issues.

Ability to manage details effectively while contributing to broader regulatory strategies.

Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.

Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD) is strongly preferred.

Educational Background

Bachelor’s degree in Engineering/ Life Sciences (advanced degree preferred).

RAC certification (U.S. or EU) is a plus.

Other Qualifications

Ability to work collaboratively and independently in a fast‑paced environment while managing multiple priorities.

Clear and effective verbal and written communication skills with diverse audiences and personnel.

Highly organized with ability to manage multiple projects/tasks simultaneously and effectively prioritize.

Proficiency in MS Word, Excel, Adobe, and PowerPoint.

Must be able to travel as needed.

Base Pay Range Min $93,680 - Max $140,520

Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Seniority level: Mid-Senior level

Employment type: Full‑time

Job function: Legal

Industries: Hospitals and Health Care

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