Senior Manager, RAQAC (Remote)

Work Flexibility: Remote

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.
• Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
• Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
• Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

What you will do

The Senior Manager, Regulatory Affairs, Quality Assurance and Clinical Affairs, is responsible for leading the Stryker Emergency Care regulatory, quality and clinical team to support RAQAC activities for the Lund (Jolife) product portfolio and to promote product innovation. This role operates within an international environment characterized by regulatory requirements and working in close collaboration with customers as well as internal stakeholders within Stryker, including RAQAC, R&D and Marketing.

• Lead a team of global regulatory and quality professionals to deliver against go to market business strategies for the Lund portfolio of products.
• 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.
• Plan, implement and maintain an effective quality management system.
• Oversee or lead management review meetings & report to management on the effectiveness of the Quality Management System and any need for improvement.
• Hold the position of Person Responsible for Regulatory Compliance (PRRC) according to EU MDR
• Direct all regulatory activities to ensure new product development and product sustainment meet regulatory requirements and customer quality expectations.
• Responsible for the resourcing, strategy and implementation of the clinical evidence portfolio to support global market access.
• Manage divisional relationship with global regulatory authorities through direct engagement on matters related to product registrations and approvals.

What you need

• You have a Bachelor's Degree In science, medicine, pharmacy, engineering, or another relevant degree; Master's degree is desired.
• You have Experience At least 12 years' in an FDA or highly regulated industry; with 3 years' people management experience. You have at least 5 years' regulatory affairs experience and you have expertise in current Quality Management System standards, i.e. ISO 13485.
• You speak Fluent English A key part of this role will be to work with international stakeholders across the world. Fluent Swedish is a distinct advantage.
• This person will get great exposure to the LUCAS ™ Chest Compression System.
• Opportunity to work on fulfilling projects with local and international colleagues within the department and well as cross functionally.
• Help shape the future of the Jolife RAQAC team to ensure we provide best in class products to our customers.
• Work in Europe's 7th best "Great Place to Work".
• Attractive flexibility in working arrangements.
• Jolife AB, a wholly owned company by Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).

• Min $122,800.00 - Max $208,700.00 USD Annualsalary 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.

Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.