1+ months

Sr Regulatory Affairs Specialist, Coronary - Santa Rosa, CA

Santa Rosa, CA 95404
Sr Regulatory Affairs Specialist, Coronary - Santa Rosa, CA


Santa Rosa, California, United States

Requisition #:


Post Date:

Oct 22, 2020


The Senior Regulatory Affairs
Specialist develops strategies for worldwide medical device approvals to
introduce new coronary Class III products to market, prepares EU and US
submissions, supports worldwide submissions and acts as a liaison with
regulatory agencies. The Sr. Specialist also assists with the training of
other regulatory affairs associates and provides work direction and mentorship
on projects of large scale.

**CVG - Coronary Products** :TheCardiac and Vascular Group
(CVG)brings all of Medtronics cardiac and vascular businesses together
into one cross-functional, collaborative operating unit to employ the full
breadth of our talent, technologies, products, services, and solutions to
address the needs of customers and patients across the globe. Coronary
Productsinclude but are not limited to coronary drug-eluting stents
(combination products), and next-generation devices for percutaneous coronary

is a cross-functional, collaborative operating unit to employ the full breadth
of our talent, technologies, products, services, and solutions to address the
needs of customers and patients across the globe. Whatever your specialty or
ambitions, you can make a difference at Medtronic both in the lives of others
and your career.


+ Acts as a core member on development teams to provideregulatory guidance and develop regulatory strategies and timelines forkey markets.

+ Lead the preparation of EU and US regulatorysubmissions for new products as required to ensure timely approval forclinical studies and market release.

+ Support China type testing and clinical study startactivities for both the China and Japan regions.

+ Support worldwide geography submissions in China,Japan, Australia and other international countries.

+ Communicate and interacts with regulatory authoritiesbefore and during the development and review of a regulatory submissionthrough appropriate communication tools.

+ Preparation of periodic reports to maintain Class IIIdevice approvals as needed.

+ Direct experience assessing global regulatory impact ofproduct changes. Evaluating proposed post-approval changes (indicationexpansion, design, significant/substantial, manufacturing) for regulatoryfiling solutions and proposes plans/strategizes (if appropriate) forchanges that do not require submissions.

+ Maintain proficiency in worldwide regulatoryrequirement and understanding of international standards for electronicmedical devices, including of key interest IEC 60601-1, IEC 60601-1-2, IEC62304, and IEC 62366 at a minimum.

+ Provide regulatory information and guidance forproposed product claims/labeling.

+ Participates in inspections/audits either performedinternally, by notified bodies, or by other international regulatorybodies by producing requested documents or answering any inquiries forinformation.

+ Assist regulatory department in the update,enhancement, and creation of internal policies and procedures. Support theregulatory department in assessment of quality management system changeassessment and reporting.

+ Provide mentorship, training and support to othermembers of the department.

+ Support assessment and recommendation of new andchanging regulations, guidance documents, requirements as needed.

**BayArea Benefits:**

+ Vanpools available from San Francisco, Albany, andNovato

+ Medtronic Incentive Plan

+ Time off: 4 weeks the first year plus 10 holidays

+ Excellent Benefits including comprehensive medicalcoverage, 401K match, and Employee Stock Purchase Plan

_Come for a job. Stay for a career._



Minimum Education required:

+ Bachelor's degree

of Experience Required:

+ Minimum of 4 years regulatory affairs or other relevantexperience with Bachelors

+ Minimum of 2 years regulatory affairs or other relevantexperience with Masters


+ Direct experience working in regulated, biotechnologyenvironment, including involvement with regulatory submissions,interactions with regulatory agencies (e.g., FDA), and working withcross-functional project teams. Sound understanding of basic Design Controls,Software Life Cycle, Risk Management, and Verification Validationprocesses

+ In depth experience with FDA requirements, guidancedocuments, IDE, PMA, 510(k) submissions, Medical Device Directive, ISO14971, ISO 13485, IEC 60601, IEC 62366, IEC 62304, and other globalregulatory requirements and quality standards. Knowledge of new MedicalDevice Regulations (MDR).

+ Ability to work in a matrixed organization andgeographically diverse business environment

+ Knowledge of GLP/GCP requirements

+ Strong negotiation skills and written/oralcommunication skills

+ Strong organizational skills and time management skills

+ Ability to multitask, support multiple projects,function on a global basis, prioritize, conduct team meetings, and meetproject deadlines

+ Ability to work within a team and as an individualcontributor in a fast-paced, changing environment

+ Proficient in MS applications (Excel, Word, Outlook)


The above statements are intended
to describe the general nature and level of work being performed by employees
assigned to this position, but they are not an exhaustive list of all the
required responsibilities and skills of this position.

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.

+ The employee is required to be independently mobile

+ The employee must be able to travel independently tovarious Medtronic buildings/sites.

+ The employee is required to interact with a computer,and communicate with co-workers

+ The employee is required to travel by car and byairplane (approx.10%), including possible International travel
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: 2020-10-27 Expires: 2021-02-04

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Sr Regulatory Affairs Specialist, Coronary - Santa Rosa, CA

Santa Rosa, CA 95404

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