Job Information
Stryker Manager, Regulatory Affairs, State Licensing in Portage, Michigan
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
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, 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 www.stryker.com
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
We are currently seeking a Manager, Regulatory Affairs, State Licensing to join our Corporate Division . This is an onsite role based in Portage, Michigan.
What you will do
The Manager, Regulatory Affairs, State Licensing, Designated Representative works with a high level of autonomy to oversee the regulatory process for products requiring governmental approval, including filing necessary applications and handling government interactions to bring medical devices to market and ensure ongoing compliance while managing a regulatory team.
This role is responsible for:
Overseeing regulatory and compliance aspects of a virtual wholesale distribution entity. This individual will be actively involved in and aware of the daily operations of the virtual wholesale entity and the supporting physical entities. The individual will maintain oversight of Quality Assurance investigations of inventory discrepancies, suspect or suspicious or fraudulent activity investigations and ensuring any required notification of federal and/or state agencies are completed.
Managing state licensing applications and renewals across multiple physical sites located within the USA.
Interpreting federal, state, and local regulations to ensure regulatory compliance, assess impact on business, and assist in implementation of any changes as appropriate.
Ensuring annual reporting of Wholesale Drug Distributor licensure information to the FDA as required under the DSCSA.
Providing leadership to regulatory team to ensure achievement of business goals and objectives by ensuring access to market of products compliant with all applicable local, state and federal agencies and regulatory bodies.
Being accountable for ensuring cross functional alignment and support to meet regulatory compliance requirements.
Directing and contributing to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy.
Leading hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes, tools and documents supporting our Global QMS.
Is aware of and knowledgeable about all policies and procedures pertaining to the operations of the virtual wholesale entity.
Review regulatory compliance requirements for changes affecting pharmaceutical, medical device and combination product state licensing.
Implement regulatory system changes to support evolving regulations and standards.
Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional and operational state licensing activities.
Ensure that new product registrations, or appropriate notification/submission of business changes, if required by a state, are conducted in compliance with state standards.
Responsible for identifying the key personnel for handling and control of prescription drugs/devices through receiving, manufacturing, and shipping.
Build and maintain working relationships with state licensing authorities.
Establish standard process to ensure appropriate resolution and management of the responsible task owner.
Chair meetings required to drive closure of regulatory issues.
Manage and provide updates for regulatory metrics. Implement appropriate enhancements.
Evaluate merger and acquisition targets for state licensing readiness and execute on quality plans post-acquisition to ensure acquired sites are compliant and acquired staff is appropriately trained.
Represent regulatory processes during internal and external audits.
Develop talent within adjacent teams to increase performance.
Maintain a high level of team engagement.
Participate in advocacy activities of a more advanced strategic nature, including DSCSA or state-level advocacy.
Ability to initiate and lead advocacy conversation in using leadership and analytical skills to structure conversation to reach consensus as a group and clearly communicate Stryker's position.
Ensure the coordination across all Stryker divisions and sites.
Ability to engage with internal stakeholders and external stakeholders.
Interact with groups within the organization, including global regulatory team, governmental affairs, legal, division subject matter experts, global process owners, hub and spoke teams, and manufacturing sites, depending on topics.
Provide information to help influencing and managing regulatory changes to prevent any business disruption.
Owns global documents and training materials on state licensing.
Updates Global Governance, RA/QA Leadership and PMO on direction and progress
Ensures global initiatives are communicated and understood by stakeholders.
Serves as the voice of the process area for Stryker.
Travels to and leads hub and spoke meetings.
Leads meetings, surveys, information-gathering, and global decisions for geographically dispersed teams.
Delivers against agreed project deadlines and reconciles implemented sites.
Communicates to leadership and stakeholders at a global level.
Leads global cultural change.
What you need
Minimum Bachelor's degree. Licensed PharmD or RPh preferred, strong preference for holding licensure for pharmaceutical practice held in CA and/or FL. If a bachelor's degree is held, the position requires attaining licensure as a designated representative in states that may have regulatory testing requirements.
Minimum of 9 years' experience required.
Minimum 3 years supervisory experience in a pharmacy or wholesale distributor where the designated representative's responsibilities included, but were not limited to, record keeping, storage, and shipment of pharmaceuticals.
Master's Degree or equivalent preferred
Knowledge and understanding of state law and federal law relating to the distribution of prescription drugs and prescription devices.
Knowledge and understanding of quality control systems.
Knowledge and understanding of the NABP and United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
Knowledge and understanding of prescription drug terminology, abbreviations, dosages, and format.
Demonstrated expertise in regulatory systems in a regulated environment.
Demonstrated project management skills.
Demonstrated verbal, written, and interpersonal communication skills.
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 (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)
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. (http:)
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 (https://careers.stryker.com/referrals/)
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.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.