JOB DESCRIPTION:

Our location in SYLMAR, CA and Scottsdale, AZ currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This team member reports into the Director of Regulatory Affairs and is responsible for the management and leadership of Regulatory Affairs activities for implantable cardiac pacemaker and defibrillator devices and accessories. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support clinical trial activities and product launches. This individual applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge of US FDA requirements and EU MDR requirements as well as other applicable EU regulations as they relate to Class III implantable medical devices and combination products is required. Working knowledge of regulatory requirements for Australia, Canada, and other countries is advantageous.

The person in this role will manage a team of Regulatory Affairs Specialists, while also managing day-to-day activities, and interacting with individuals across international locations and time zones, cultures and languages. A portion of time will be dedicated to managerial activities, employee development, strategic oversight and cross-functional alignment to meet regulatory requirements.

What You Will Do:

Recruit, coach and develop Regulatory Affairs talent.

Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of Regulatory Affairs and organizational objectives.

In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.

Provides direction and guidance to Regulatory Affairs specialists with varied degrees of latitude and independence in their assignments.

Keeps the organization's vision and values at the forefront of decision making and action.

Demonstrates effective change management and leadership.

Builds strategic cross functional partnerships to further Regulatory Affairs and organizational objectives.

May develop and execute functional and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.

Monitors compliance with company policies and procedures (e.g. compliance with FDA, EU MDR, medical device regulations in other geographies, etc.).

Makes decisions regarding work processes or operational plans and schedules to achieve functional objectives.

May help develop, monitor and appropriately adjust the annual budget for US and EU Regulatory Affairs submissions.

Develops regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.

Assesses proposed new or updated regulations and communicates new requirements to the organization.

Lead the preparation and submission of regulatory documents (e.g., IDEs, PMAs, 510(k)s, EU MDR Technical Files) for implantable CRM devices.

Develop and execute regulatory strategies to support new product development, clinical trials, and global market access.

Serve as the regulatory representative on cross-functional project teams, providing guidance on regulatory requirements and risk mitigation.

Interface with regulatory agencies (e.g., FDA, Notified Bodies) and manage responses to inquiries and deficiency letters.

Monitor and interpret evolving global regulatory requirements and communicate their impact to internal stakeholders.

Support post-market regulatory activities including labeling updates, annual reports, and change assessments.

Mentor junior regulatory staff and contribute to the development of regulatory best practices.

Required Qualifications

• Minimum 6 years of minimum six years medical device regulatory experience.

• Extensive experience with US and global medical device regulations and submissions.

• Experience working in a broader enterprise/cross division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multi-tasks, prioritizes and meets deadlines in timely manner.

• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

• Ability to travel approximately 15%, including internationally.

• Ability to maintain regular and predictable attendance

Preferred

8+ years experience in Regulatory Affairs.

Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions for new and on market products.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Ability to work independently with no oversight.

Ability to identify and solve problems in a strategic manner.

Ability to manage complex projects.

Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.

Advanced Degree or additional professional training in regulatory affairs.

Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is a plus.

Experience working with medical device combination products.

Experience working with medical devices for the treatment of heart disease is a plus.

Demonstrated experience at a supervisory/managerial level.

Strong interpersonal and leadership skills. Effective communication skills, business problem solving, ability to lead change in an organization and ability to conduct strategic analysis are key skills for this position.

Strong working knowledge of the various lifecycle processes and knowledge of the systems supporting the processes. Possess cross-functional knowledge of the lifecycle processes and be able to assess impact of proposed changes on all areas.

Ability to build cross-divisional relationships and support for process improvements and must be able to develop implementation plans which support adherence to best practices.

Must possess knowledge of Quality Systems and their supporting processes. Must possess departmental and budget management skills.

The base pay for this position is
$114,000.00 - $228,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
CRM Cardiac Rhythm Management

LOCATION:
United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:
United States > Scottsdale : 8300 E. Pacesetter Way

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)