**Job Description Summary**

**Job Description**

**Be part of something bigger!**

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

**Position Summary:**

This entry level position will be responsible for preparing US and international regulatory submissions, providing regulatory support to the development team, and ensuring compliance with required regulations for assigned projects.

**This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy and is anticipated to last approximately through May 31, 2024.**

**Responsibilities:**

+ Participate in product development/line extension teams as the need arises to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals.

+ Drive Labeling and Copy review for products for domestic and International markets.

+ Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.

+ Prepares U.S. FDA submissions (e.g., IDE, PMA, annual reports) as required and per applicable SOPs.

+ Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards.

+ Ensure adequate documentation of compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.

+ Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and BDPI Notified Body.

**Qualifications:**

+ Bachelors of Science or technical degree or equivalent experience

+ 0-3 years experience in Regulatory Affairs within medical industry or related proven industry experience (medical device, pharmaceutical and/or healthcare)

+ Excellent written and verbal communication and technical writing skills

+ Strong organizational and interpersonal skills

+ Ability to optimally manage multiple projects with shifting priorities

+ General knowledge of FDA and European medical device regulations, including IDE, PMA, MDD & MDR beneficial

+ Able to apply independent decision making and analytical thinking skills

+ Proficiency with PC computer and Microsoft Office software

+ Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred

+ Ability to work independently with minimal direction

**Physical Demands:**

While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee is occasionally required to bend, lift, reach or stoop. Employee must be able to wear personal protective equipment. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

**Work Environment:**

The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

_For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law._

**Why Join Us?**

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson, and Company are an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

\#LI-PRO

PDN

**Primary Work Location**

USA AZ - Tempe Headquarters

**Additional Locations**

**Work Shift**

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Why RA/QA at Stryker?**

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? **Here are 10 reasons to join our Regulatory Affairs team:** https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker Emergency Care is seeking to hire a Staff Regulatory Affairs Specialist to join our Medical Division in Redmond, WA. This role can be hybrid in Redmond, WA or remote anywhere in the US.

As the Senior Regulatory Affairs Specialist, you will engage in technical and scientific regulatory activities to include project management, writing, coordination, and execution of regulatory documentation for Stryker’s AED and LIFEPAK 15 Monitor/Defibrillator product portfolio. LIFEPAK 15 monitor/defibrillator - proven clinical performance | Stryker (strykeremergencycare.com) (https://www.strykeremergencycare.com/products/devices/LIFEPAK-15/)

These devices send data ahead to the receiving caregiving team to save time, ease handoffs, and improve patient outcomes. Emergency Care training videos and survivor stories | Stryker (strykeremergencycare.com) (https://www.strykeremergencycare.com/learn-and-train/videos/)

Stryker will offer you a competitive total rewards package, including competitive base salary, performance bonus, and benefits. We also offer other non-financial rewards, and engaging work environment and meaningful career advancement opportunity. Stryker Benefits (https://www.smashfly.ai/01113)

**Who we want**

+ **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

+ **Self-directed initiators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

+ **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

**What you will do**

+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

+ Evaluates proposed products for regulatory classification and jurisdiction

+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

+ Negotiates with regulatory authorities throughout the product lifecycle

+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

+ Assists other departments in the development of SOPs to ensure regulatory compliance

+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams

+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

+ Provides regulatory information and guidance for proposed product claims/labeling

+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency

+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

**What you need:**

+ BS in Engineering, Science, or related degree; or MS in Regulatory Science

+ 2 years’ experience in Medical Device Regulatory Affairs

**Know someone at Stryker?**

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

**About Stryker**

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visitwww.coopervision.com *Who We Are* Paragon Vision Sciences, Inc., a Cooper Vision specialty eye care company, is a world leading manufacturer of specialty contact lenses and oxygen permeable contact lens materials. Our CRT® lens (a class three medical device) is considered the lens of choice by many eye care professionals around the world. Paragon’s office is located in Gilbert, Arizona. *Why Work With Us* We are certified as aGreat Place to Work®! Our environment recognizes each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We are friendly, inventive, and dedicated. We don’t quit until the job is done right! Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving other’s visual health and quality of life. *Job Summary:* Maintains departmental databases and filing systems for regulatory documentation. Ensure timely preparation of organized and scientifically valid submissions while maintaining a comprehensive technical dossier database. Participates in commercial and manufacturing operations cross-functional teams. Ensures compliance with regulatory requirements for the site including marketing and labeling review. Regulatory Affairs Specialistalso shares the responsibilities of the Person Responsible for Regulatory Compliance with RAQAManager and is responsible for the clauses of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745. *Essential Functions & Accountabilities:* * Prepares documents to support local and international registration(s), re-registrations due to internal company or external government changes and renewals for expiring registrations * Assists with data entry and maintenance of regulatory files and tracking databases to ensure accurate access to company regulatory information and registration status of company products * Maintains awareness and working knowledge of existing, changed, new and future regulations as they relate to international regulatory bodies, company products, procedures, and manufacturing changes. * Working knowledge of ISO 13485, 21 CFR 820, MDD, MDR and other applicable quality system regulations. * Acts as back up to various QA activities including complaint handling, internal auditing, etc. * Reviews registration dossiers prepared by Regulatory Consultants * Assist with Custom clearances(s), import licenses, release of product per registration status, and authorization letters as required. * Provides regulatory support to product/teams to assure international requirements are incorporated throughout life cycle of product. Supports Product Transfers, Internal Company Change Assessments, and New Product Introduction projects. * Responds to inquiries during inspection/audits assessment by notified bodies or other international regulatory bodies * Reads and analyzes data in a variety of databases, including Excel, additional databases knowledge is a plus. * Compile request and obtain Certificate to Foreign Government (CFG) for products. Sent documents to proper notarization/consularization for international requirements. * Submit adverse events and recall reports to Regulatory Agencies * Performs related duties as required *Travel:*Travel may be required, up to 5%. *Qualifications* *Knowledge, Skills and Abilities:* * In In-depth understanding of the applicable international standards,BS EN ISO 13485:2016,MDR,EU Medical Device Directive (MDD 93/42/EEC),and other regulatory requirements as required by the countries/markets where products are distributed. * Self-motivated and internally driven with ability to work independently. * Ability to read and understand technical material. * Excellent attention to detail * Excellent written and verbal communication skills. * Excellent organizational skills. * Computer literate, with intermediate skill in the use of Word, Excel, PowerPoint and Outlook. * Ability to work effectively either alone or as part of a team. * Managing time effectively and completing tasks on time with general supervision. * Flexible and able to self-manage multiple priorities. * Careful attention to detail to ensure accurate and precise execution of work tasks and procedures. * Excellent verbal and written communication skills both in English and Hebrew. *Work Environment:* * Office environment * Able to work long periods of time in a normal office environment, while sitting and working on a computer. * Overtime is required *Experience:* * Minimum four (4) yearsof professional experience in regulatory affairs or in quality management systems relating to medicaldevices. * Strong knowledge of international business, regulatory environments, regulations and legal product registration processes is required, as well as proficient product knowledge acquired through experience. Strong problem-solving ability, analytical and communication skills. *Education:* * B.Sc. in Chemical / Biochemical / Biotechnology / Materials Science Engineering * Internal and Lead auditor certification- advantage #LI-LS1 **Job:** **RAQA* **Organization:** **CVI Regulatory Affairs* **Title:** *Regulatory Affairs Specialist* **Location:** *Arizona-Gilbert* **Requisition ID:** *GIL0053*