Stryker Corporation

Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.. Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.. Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

director regulatory affairs

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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance 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
Position Summary:
Provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit's drug product. Interacts with the business unit's cross-functional leadership team to support the direction, strategy, and growth of the organization, specifically related to the business unit's drug and combination product(s). Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
Essential Duties and Responsibilities:
* Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level.
* Creates long term regulatory strategy for drug products, provides input on combination products, and identifies team needs by understanding the industry and regulatory landscape in combination with the business priorities and goals.
* Manages a regulatory affairs team responsible for the division's pharmaceutical products. Hires, trains, develops, coaches/ mentors and motivates staff. Conducts performance management.
* Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally. Regulatory pathways may include INDs, NDA or sNDA, DINAs, etc.
* Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
* Leads team in development and implement pharmaceutical quality system and process requirements for business in order to ensure compliance to external regulations and standards. Responsible for commercial drug product disposition and release in addition to Quality Assurance responsibilities. Viewed as pharmaceutical regulatory expert within business.
* Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals. Represents pharmaceutical aspects in external agency audits/inspections.
* Stays abreast of external pharmaceutical regulatory requirements and expectations.
Education & Special Trainings:
* Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related
* RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
Qualifications & experience:
* Minimum 15 years of experience, including 10 years in an FDA regulated industry
* 5 years of managerial experience preferred
* Experience with successful NDA and DINAs. Prefer additional experience with IDEs/ 510(k)s and/or combination products.
Physical & mental requirements:
* Travel approximately 25%
* Manage complex technical questions and navigate through uncertainty
* Mental drive to operate at high level for long project duration
* Ability to analyze complex data
* Ability to analyze and understand regulatory requirements and standards
* Ability to communicate and present to various stakeholders, both internally and externally
* Strong organizational skills
* Self-initiated
* Demonstrated ability to lead complex cross functional teams and projects
$145,700 - $321,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.? Actual minimum and maximum may vary based on location.? Individual pay is based on skills, experience, and other relevant factors.
About Stryker
Our benefits:
* 12 paid holidays annually
* Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
* Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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 on our referral page
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.<br/><br/>#J-18808-Ljbffr

START NEW SEARCH