Senior Regulatory Affairs Specialist

Medtronic

Senior Regulatory Affairs Specialist

Boulder ,

Colorado

Apply Now

Senior Regulatory Affairs Specialist – Acute Care & Monitoring
The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.
Location
This job is located in Boulder, CO and has a strong preference for local candidates. The expectation is for employees to be on-site around 1 day a month and to travel (10% via car or plane) as needed.
Operating Unit
The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM. ACM is a $2B global business focused on airway management and patient monitoring technologies.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life
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 CE Mark Technical Files (MDD and MDR) for product changes and/or new products as required to ensure timely approvals for market released products.
Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval.
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.
Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
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.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Other duties as assigned
Must Have: Minimum Requirements
Bachelor's Degree with 4+ years of experience in regulatory affairs and/or quality assurance
OR
An advanced degree with 2+ years of experience in regulatory affairs and/or quality assurance
Nice to Have
4+ years of medical device regulatory submission experience.
U.S. and EU regulatory submission experience (510k and EU MDR)
Experience with international standards (ISO, GHTF, ICH).
Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
Experience working with cross-functional teams.
Experience working with technical documentation.
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.
Experience with Agile
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. Let’s 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Compensation
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .
The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.
At Medtronic, most positions are posted on our career site for at least 3-7 days.
86000
129000
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.

#J-18808-Ljbffr