12 days old

Sr Regulatory Affairs Specialist Patient Monitoring

Medtronic
Boulder, CO 80305
Sr Regulatory Affairs Specialist Patient Monitoring

Location:

Boulder, Colorado, United States

Requisition #:

200005R0

Post Date:

Mar 25, 2020


**Senior Regulatory Affairs Specialist -Patient Monitoring -Boulder, Colorado**


The **Senior Regulatory Affairs Specialist** provides regulatory leadership for RGI product lines and is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals. The Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He / She is responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc..) and to recommend strategies for clinical studies and evaluations.


**Careers that Change Lives**


**A Day in the Life / Responsibilities:**


+ Is the Regulatory Representative for RGI and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Product Development Process, and recommends and develops detailed regulatory strategies for most efficient and effective approvals of regulatory applications for the business.

+ Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

+ Prepare FDA submissions and create and update CE Mark Technical Files documents (MDD, MDR, RoHS, etc.) according to international guidelines for product changes and/or new products as required to ensure timely approvals for market released products.

+ Prepare submissions and reports for FDA and support other international agencies as required by product status. May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

+ Supports the international regulatory team, as needed, with inputs into the registration package they prepare and to address questions received from government agencies.

+ Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Advise internal stakeholders (marketing, manufacturing, RD, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.

+ Ensure personal understanding of all quality policy/system items that are personally applicable.

+ Follow all work/quality procedures to ensure quality system compliance and high-quality work.

+ Support post market regulatory compliance activities for US/EU product approvals.

+ Develop and maintain regulatory affairs department procedures and process improvements.

+ Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct

+ Assist in keeping company informed of regulatory requirements in the US and EU.


**MITG**


The **Minimally Invasive Therapies Group (MITG** ) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions


**RESPIRATORY, GASTROINTESTINAL INFORMATICS (RGI)** offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.


This 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.


Medtronic is a $30.5 Billion company with 90,000+ employees in more than 160 countries.


**_Come for a job. Stay for a career._**


**MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):**


Bachelor's Degree

4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelors Degree.

Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).


**DESIRED/PREFERRED QUALIFICATIONS:**


4+ years regulatory submission experience.

Experience with international standards (ISO, GHTF, ICH).

Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).

Experience with medical devices (510(k))

Experience working with cross-functional teams.

Experience working with technical documentation.

Project management skills.

Product development experience.

Knowledge of Medtronic procedures and systems.

Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.

Strong oral and written communication skills.

Effective interpersonal skills.

Effective team member.

Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

Ability to effectively manage multiple projects and priorities.

Proficient skills with MS Word, MS Outlook, MS Excel.


**PHYSICAL 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.

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.

Must be able to travel independently to various Medtronic buildings/sites.

Must be able to travel by plane and by car.(10%) No travel required during the COVID-19 crisis


Bachelor's Degree

4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelors Degree.

Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).


**DESIRED/PREFERRED QUALIFICATIONS:**


4+ years regulatory submission experience.

Experience with international standards (ISO, GHTF, ICH).

Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).

Experience with medical devices (510(k))

Experience working with cross-functional teams.

Experience working with technical documentation.

Project management skills.

Product development experience.

Knowledge of Medtronic procedures and systems.

Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.

Strong oral and written communication skills.

Effective interpersonal skills.

Effective team member.

Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

Ability to effectively manage multiple projects and priorities.

Proficient skills with MS Word, MS Outlook, MS Excel.


**PHYSICAL 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.

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.

Must be able to travel independently to various Medtronic buildings/sites.

Must be able to travel by plane and by car.(10%) No travel required during the COVID-19 crisis


Bachelor's Degree

4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelors Degree.

Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).


**DESIRED/PREFERRED QUALIFICATIONS:**


4+ years regulatory submission experience.

Experience with international standards (ISO, GHTF, ICH).

Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).

Experience with medical devices (510(k))

Experience working with cross-functional teams.

Experience working with technical documentation.

Project management skills.

Product development experience.

Knowledge of Medtronic procedures and systems.

Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.

Strong oral and written communication skills.

Effective interpersonal skills.

Effective team member.

Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

Ability to effectively manage multiple projects and priorities.

Proficient skills with MS Word, MS Outlook, MS Excel.


**PHYSICAL 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.

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.

Must be able to travel independently to various Medtronic buildings/sites.

Must be able to travel by plane and by car.(10%) No travel required during the COVID-19 crisis


**MITG**


The **Minimally Invasive Therapies Group (MITG** ) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions


**RESPIRATORY, GASTROINTESTINAL INFORMATICS (RGI)** offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.


This 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.


Medtronic is a $30.5 Billion company with 90,000+ employees in more than 160 countries.


**ABOUT MEDTRONIC:**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.


**EEO STATEMENT:**

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.


This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees


**DISCLAIMER:**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.


**_Come for a job. Stay for a career._**
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.

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Posted: 2020-03-24 Expires: 2020-05-03

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Sr Regulatory Affairs Specialist Patient Monitoring

Medtronic
Boulder, CO 80305

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