Spok, Inc. Director, Regulatory Affairs (21-106) in Minneapolis, Minnesota
Director, Regulatory Affairs (21-106)
Go behind the scenes in Spok’s Eden Prairie, MN office by watching this video: Transforming an Industry: What It's Like to Work at Spok (https://vimeo.com/262030951) . You’ll learn about the solutions Spok develops, and why collaborating to build them means so much to our employees. You’ll also get a feel for our company culture of collaboration, and the underlying beliefs, values, and people that make Spok a great place to work.Summary:
Reporting to the CTO, the Director of Regulatory Affairs, will lead the strategic direction and operational aspects of regulatory compliance and submissions for Spok’s FDA Class II medical devices. The Director will collaborate with executive management including the CTO and CIO in developing a comprehensive strategic plan to rearchitect Spok’s current Quality Management System to be one based on ISO and other relevant standards. The Director will be expected to develop and maintain strong relationships with related regulatory bodies, first in the US, Canada and Australia and then with our future Notified Body for the European Union (EU). Finally, the Director will lead efforts in obtaining regulatory approvals for software and FDA approved medical devices from regulatory agencies in anticipation of international expansion.
This position will also collaborate with the CIO to ensure alignment of software business needs related to all relevant information security, and privacy regulations and standards, as well as to ensure alignment with security frameworks and certifications.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Collaborates with the CTO and CIO to influence and shape the direction of Spok’s Quality Management System (QMS) including recommendations regarding market, policy and practice
Develops and recommends strategic direction and priorities for regulatory and quality assurance, working with product strategy, product engineering and marketing leadership to define regulated development projects including strategies, objectives, work plans, milestones and deliverables.
Recommends and implements regulatory strategies for clinical workflows requiring Institutional Review Board (IRB) approvals and clinical study design.
Assists with developing and implementing departmental best regulatory practices.
Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/clinical and regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Oversees preparation and submission of domestic and international regulatory applications as appropriate as well as internal regulatory file documentation.
Assists in establishing regulated development project priorities, allocating resources and workload.
Reviews and edits submissions prepared by team members.
Develops and presents Regulatory Affairs updates for management. Participates on management teams and provides regulatory guidance as appropriate.
Oversees review of device labeling and promotional materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
Reviews and signs-off on software product and manufacturing changes for compliance with applicable regulations.
Provides Corrective and Prevention Action (CAPA) support to regulatory team as well as cross-functional partners.
Establishes and supports a work environment of continuous improvement that supports Spok’s Quality Policy, Quality System and the appropriate regulations for the area they support.
Collaborates with HR to ensure employees receive appropriate regulatory compliance training and their training is documented.
May supervise 1-3 employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training/mentoring employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Worksite Location: Eden Prairie, MN Office
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Bachelor’s degree preferably in a scientific, technical discipline or project management, Regulatory Affairs Certification (RAC) is strongly preferred. Master’s degree level of education is desired.
10+ years Regulatory Affairs or related field, Medical Device experience required. International experience preferred
3+ years of management experience required
Demonstrated success in management of regulatory submissions activities including FDA, Health Canada and Notified Body experience
Demonstrated success as the Regulatory Affairs lead on large cross-functional development teams
Preferred Skills and Qualifications:
Strong understanding of product development process and ability to effectively partner cross-functionally to develop and influence sound product strategies
Strong technical knowledge of medical software design controls and healthcare IT applications
Strong technical understanding of relevant procedures, practices, and associated medical terminology
Thorough knowledge of product development process and design control
Excellent research and analytical skills
Ability to manage multiple projects simultaneously
Excellent written and oral communication, technical writing and editing skills
Strong leadership, interpersonal and influencing skills
Ability to work independently with minimal supervision
Ability to collaborate with cross-functional partners/teams
Stellar people skills and strong conflict management and resolution skills: individual must be capable of inspiring and influencing to grow, learn and contribute; a catalyst for positive, collaborative change
Intellectually curious with excellent analytical and problem-solving skills; able to make quick decisions
Ability to drive to pragmatic solutions to complex problems taking short-term and long-term goals into consideration
Willing to identify, own, and solve problems independently and as part of a team
Highly adaptable, recognizing when strategies are working and when they are not
Optimistic, driving to positive outcomes for the team
Spok, Inc., a wholly owned subsidiary of Spok Holdings, Inc. (NASDAQ: SPOK), headquartered in Springfield, Virginia, is proud to be a global leader in healthcare communications. We deliver clinical information to care teams when and where it matters most to improve patient outcomes. Top hospitals rely on the Spok Go® and Spok Care Connect® platforms to enhance workflows for clinicians and support administrative compliance. Our customers send over 100 million messages each month through their Spok® solutions. When seconds count and patients’ lives are at stake, Spok enables smarter, faster clinical communication. For more information, visit spok.com or follow @spoktweets on Twitter.
Spok is a trademark of Spok Holdings, Inc. Spok Go and Spok Care Connect are trademarks of Spok, Inc.
At Spok, Inc., we provide equal opportunity to all employees and applicants without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, marital status, membership or activity in a local human rights commission, status with regard to public assistance or any other protected status or characteristic. Should you have a disability and need assistance or accommodation in the application process, contact Human Resources at 1-800-852-8935