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Basic Function:

+ Accountable for maintaining, monitoring, and reporting post market surveillance performance to ensure regulatory requirements are met with external regulatory bodies/agencies.

+ Responsible for Technical Publications organization, ensuring compliant labeling (IFUs, labels, etc) and on-time support of New Product Development.

+ Leads organization engaged in regulatory compliance and quality systems activities such as Complaint Handling, Internal Auditing, CAPA and Field Actions.

+ Provide 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.

+ Accountable for ensuring cross functional alignment and support to meet regulatory compliance requirements.

+ Direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy.

Responsibilities:

+ Lead the Regulatory Compliance organization including people management and ensuring global regulatory compliance within associated division or business units

+ May serve as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation

+ May take responsibility for handling regulatory agency audits and communication with regulatory agencies.

+ Accountable for effective product field action execution including customer interactions and reporting to regulatory agencies.

+ Influence initiatives, decisions and processes for the organization.

+ Responsible for Technical Publications organization, supporting both new product development and sustaining/compliance activities.

+ Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets.

+ Implement regulatory system changes to support evolving regulations and international standards.

+ Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities.

+ 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.

+ Represent regulatory processes during internal and external audits.

+ Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.

+ Recruit, select, and on-board top talent.

+ Develop talent within team to increase performance. Actively address performance issues on team.

+ Maintain a high level of team engagement.

+ Participate in advocacy activities of a more advanced strategic nature.

Skills/ Experience:

+ This is a management position that contributes and achieves results through others. The role is responsible for managing subordinates in professional jobs or managing through subordinate managers / supervisors or is a leader of process that achieves results through others, whom are not direct reports. Job requires a broad and comprehensive understanding in multiple disciplines relevant to the business. The job is expected to establish strategic plans and/or operational programs that require a sound understanding of the underlying theories underpinning the subject area. The job has full management responsibility including the management of numerous teams of managers/professionals, planning for the teams' future needs and operations. There will be financial accountability for independent budgets.

+ Minimum of 10 years experience preferred

+ 2 - 4 years of Management Experience

+ For PRRC designation:

+ Minimum of 1 year professional experience in regulatory affairs or in quality management systems relating to medical devices required if degree is in preferred disciplines listed below

+ Minimum of 4 years professional experience in regulatory affairs or in quality management systems relating to medical devices required if degree is not in preferred disciplines listed below

+ Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.

+ Demonstrated expertise in regulatory systems in a regulated environment.

+ Demonstrated project management skills.

+ Demonstrated verbal, written, and interpersonal communication skills.

+ Demonstrated ability to work in a team environment, interact effectively with management from other functions.

+ Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets.

+ Demonstrated ability to initiate work.

+ Demonstrated analytical ability.

+ Demonstrated ability to make effective decisions.

+ Experience with recruiting, people development.

+ Influence across the organization.

Education/ Training:

+ Bachelor’s degree required, life sciences, nursing or engineering (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc. preferred)

+ Regulatory Affairs Certification desired.

+ Master's Degree or equivalent 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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required 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.