8 days old

Senior Regulatory Affairs Specialist

Siemens
Boston, MA 02109
**Nows our time to inspire the future of healthcare together.**



Siemens
Healthineers is a leading global medical technology company with over 170 years
of experience and 18,000 patents. More than 48,000 dedicated
colleagues in over 70 countries are driven to shape the future of healthcare.
We stand with our customers around the world to support them in delivering high
quality care to their patients. An estimated 5 million patients across the
globe benefit every day from our innovative technologies and services in
the areas of diagnostic and therapeutic imaging, laboratory diagnostics and
molecular medicine, as well as digital health and enterprise services. This is
what truly matters to us.



Join our team
now at Siemens Healthineers as Sr. Regulatory
Affairs Specialist



This
position reports to the Sr. Manager of Regulatory Affairs, and is responsible
for the creation, preparation and coordination of regulatory submissions and
approvals in the domestic and international markets. The Sr. Regulatory Affairs
Specialists works with the regulatory and clinical teams to develop and
implement regulatory and clinical strategy to get precision robotic systems
through various regulatory agencies. As part of a multi-disciplinary group,
this position also contributes to the design, development and product launch of
Corindus innovative robotic systems that bring improved care to patients and
physicians.



**PRIMARY RESPONSIBILITIES**




Work with the Sr Manager of Regulatory Affairs to
determine effective regulatory strategies across a variety of projects and
issues




Work independently prepare document packages for
regulatory submissions including 510(k)s, Design Dossiers, Technical Files,
Device License Applications, Investigational Device Exemptions, and Pre-market
Approval Applications




Advise company stakeholders on regulatory strategy as
part of the product development process




Track and coordinate regulatory submission activities
to ensure timeliness and commitments are met




Coordinate responses to regulatory agencies and
notified bodies as part of the submission and approval process




Review and approve Engineering Change Orders in
accordance with regulatory requirements




Participate in new product development teams and
communicate regulatory requirements for product development; facilitate internal
compliance with those requirements




Review and approve test protocols to support
regulatory submissions




Review device labeling and advertising material for
compliance with submissions




Assist in regulatory compliance activities, including
but not limited to Notified Body Audits, FDA Inspections, and other regulatory
agency inspections and audits




Maintain regulatory files




Perform internal audits of the Quality System




Analyze product complaints and make recommendations
regarding their reportability




Other duties as assigned



**DESIRED SKILLS AND EXPERIENCE**




Bachelors in Engineering or Science required.
Advanced degree preferred.




At least 5 years of experience in regulatory affairs
in the medical device, biotech or pharmaceutical environment




Regulatory compliance experience in the medical
device area preferred




Knowledge of applicable US and EU medical device
regulations required. Knowledge of other markets is preferred




Regulatory submission experience in US and EU,
including but not limited to 510(k), PMA, DeNovo, Technical Files, STED




Working knowledge of GMPs and GCPs required




Strong written, oral, and interpersonal communication
skills including proficient knowledge of regulatory terminology; additional
knowledge of medical terminology desired




Proficiency in MS Office applications: Word, Excel,
PowerPoint; web-based applications; Adobe Acrobat



At Siemens Healthineers, we value those who dedicate their energy
and passion to a greater cause. Our people make us unique as an employer in the
med-tech industry. What unites and motivates our global team is the inspiration
of our common purpose: To innovate for
healthcare, building on our remarkable legacy of pioneering ideas that
translate into even better healthcare products and services. We recognize that
taking ownership of our work allows both us and the company to grow. We offer
you a flexible and dynamic environment and the space to move beyond your
comfort zone to grow both personally and professionally.



If you want to join
us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers



If you wish to find out more about Siemens
Healthineers before applying, please visit: https://usa.healthcare.siemens.com/about



As an equal-opportunity employer we are happy
to consider applications from individuals with disabilities.



\#LI-ES1



**Organization:** Siemens Healthineers



**Company:** Siemens Medical Solutions USA, Inc.



**Experience Level:** Experienced Professional



**Job Type:** Full-time



**Equal Employment Opportunity Statement**

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their 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. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .



**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .



**California Privacy Notice**

California residents have the right to receive additional notices about their personal information. To learn more, click here at https://new.siemens.com/us/en/general/legal/us-internet-privacy-notice-state-rights.html .

Categories

Posted: 2020-03-23 Expires: 2020-04-22

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Senior Regulatory Affairs Specialist

Siemens
Boston, MA 02109

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