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Senior Regulatory Affairs Specialist - Robotic Surgery

North Haven, CT 06473
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Senior Regulatory Affairs Specialist - Robotic Surgery


Boston, Massachusetts, United States

Requisition #:


Post Date:

Apr 06, 2021


Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes.Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.Were making that exciting future possible and disrupting one of the biggest and fastest growing markets in healthcare with a game-changing portfolio of robotic and data analytics technologies, services, and solutions.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.Come strengthen your specialized skills and enhance your expertise. Well help you to expand your expertise with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way thats best for you. Together, we can confront the challenges that will change the face of healthcare.

**Careers That Change Lives**

As **Senior Regulatory Affairs Specialist** ,you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory authorities. You must have a track-record of working effectively with teams and developing innovative regulatory strategies for novel electromechanical medical devices.

**A Day in the Life**

The **SeniorRegulatory Affairs Specialist** is expected to perform with minimal supervision and is responsible for the full product lifecycle, including influencing department processes, writing/developing and supporting global regulatory submissions, and ensuring timely and high-quality execution of all other regulatory deliverables as assigned. Your focus will be:

+ Prepare and maintain US, EU, and support other international submissions for new product and changes to existing product to ensure timely approvals of clinical studies and marketing authorization. Specifically,

+ 510(k) for initial product, expanding indications for use, and design changes in accordance with 21 CFR Part 807

+ EU Technical Document in accordance with Regulation (EU) 2017/745 and 2006/42/EC

+ US Investigational device exemption (IDE) in accordance with 21 CFR Part 812

+ US Pre-submissions (Q-subs)

+ Develop global regulatory strategies. Ensure strategy outputs are properly communicated to development teams and business. Specifically,

+ Device classification

+ Identification of all potentially applicable rules and government expectations

+ Global registration timelines

+ EU GSPR and MDSAP list of Essential Principles, including list of critical standards

+ Support product development by guiding teams on complex regulatory issues, including reviewing scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents. Specifically,

+ Software life-cycle and cybersecurity

+ Quality management system

+ Medical electrical equipment, including systems

+ Human factors and usability

+ Risk management

+ Preclinical (animal) studies

+ Sterilization and biocompatibility, including reusable/resterilizable devices

+ Pre- and post-market clinical studies, including IDE, PMCF, CEP

+ Valid scientific evidence and substantial equivalence topics

+ Support market-released products, as necessary. This includes reviewing most changes affecting outputs of design controls.

+ Assist quality management system audits, including regulatory parts of MDSAP and EU.

+ Review/approve and guide the development of advertising and promotional material.

**Must Have: Minimum Requirements**

+ Bachelors Degree in scientific discipline

+ Minimum 4 years medical device regulatory experience

+ Or an advanced degreewith at least 2 years in a regulatory role for medical devices

**Nice to Have**

+ Advanced Degree

+ RAC certification(s)

+ Regulatory experience involving electromechanical (including software) devices.

+ US Class II and EU Class IIb device experience and in-depth knowledge of US FDA regulations (Title 21) and EU CE Marking directives.

+ History of successful US 510(k) submissions, Q-submissions, EU technical files

+ In-depth knowledge of preclinical and clinical study rules/regulations.

+ Excellent written/oral communication skills.

+ Thorough knowledge of other regulations pertaining to the commercialization of medical devices.

+ Thorough/Working knowledge of MDSAP and EU. Specifically,

+ US Quality System Regulation, Canadian Medical Device Regulation, EU Medical Device Directive or Regulation (EU) 2017/745, and ISO 13485:2016.

+ Experience with US Class III device submissions, including IDE

+ Experience with SiMD and SaMD, including AI and Machine Learning

+ Regulatory Compliance competency (Inspections, Audits, Field Actions)

+ International Regulatory submissions experience

+ Clinical Trial experience, including IDE submissions

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2021-02-18 Expires: 2021-05-16
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North Haven, CT 06473

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