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
Who we want
- Effective communicators. People who collect and interpret information accurately and can concisely communicate results and recommendations to stakeholders, senior management, and their teams.
- Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
- Quality-focused team drivers. People who motivate their team to deliver the highest quality products and solutions in a timely manner.
- Insightful advisors. Managers who lead strategy development and provide guidance and consultation to internal and external teams.
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Position Summary
The Senior Manager, Regulatory Affairs & Quality Assurance, is responsible for leading Stryker Emergency Care regulatory and quality professionals to support RAQA activities for the HeartSine AED product portfolio.
What you will do:
- Lead a team of regulatory and quality professionals to deliver against go to market business strategies for the HeartSine AED product portfolio.
- Monitor, track and actively assess evolving regulations, guidance, warning letters and regulatory policies.
- Interpret and apply governmental regulations, agency guidelines, and internal procedures to assure compliance, and assist the organization in driving implementation.
- Develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory and quality processes.
- Serve as the PRRC with overall responsibility for conformity of devices, maintenance of technical documentation and post market obligations.
- You may also hold the position of Management representative deputy regarding quality and regulatory related issues.
- Direct all regulatory activities to ensure new product development and product sustainment meet regulatory requirements and customer quality expectations.
- Establish annual budgets and quarterly forecasts.
- Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
- Represent regulatory and quality processes during internal and external audits.
- Recruit, select, and on-board top talent and maintain a high level of team engagement
- Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.
What you will need:
- Level 6 qualification in a science, engineering or related Advanced degree preferred.
- Master's Degree or equivalent preferred
- RAC desired
- Minimum of 8+ years experience preferred.
- Minimum of 5+ years in a people management role
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
- Demonstrate technical knowledge of medical device product lines.
- Demonstrated experience with trending and analysis
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.