Manager, Regulatory Affairs

$126.5k - $210.7k

Stryker Orthopaedics

Stryker seeks an experienced regulatory affairs manager to lead global strategy for the Surgical Technologies business. The role combines strategic planning, team leadership, and cross-functional collaboration in a hybrid position based in Michigan with significant stakeholder interaction.

Responsibilities

Lead and develop high-performing regulatory team with clear objectives and performance management
Translate evolving regulatory requirements into actionable plans enabling market access
Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing, and Commercial teams
Oversee regulatory submissions, registrations, agency interactions, inspections, and audits
Lead negotiations with global regulatory authorities, notified bodies, and external stakeholders

Requirements

Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related scientific field
Minimum 6 years experience in medical device, pharmaceutical, biotechnology, or regulated industry
Demonstrated experience preparing, reviewing, or overseeing regulatory submissions and authority interactions
People management experience or track record leading cross-functional programs
Knowledge of FDA, EU, and international regulatory requirements including ISO standards
Fluency in English

Compensation: $126,500 - $210,700 USD Annual

Apply

Vacancy posted 17 days ago

Similar jobs that could be interesting for youBased on the Manager, Regulatory Affairs in Portage, MI vacancy

Manager, Regulatory Affairs
$126.5k - $210.7k
Work Flexibility: HybridStryker is seeking a Manager, Regulatory Affairs to support our Surgical Technologies business. This hybrid role is based in Portage, Michigan, with an expectation of onsite collaboration a minimum of three days per week.As the Manager, Regulatory...
Suggested
Full time
For contractors
3 days per week
Stryker
Portage, MI
1 day ago
Chief Managed Care Officer
...Chief Managed Care Officer Southwest Michigan Behavioral Health • Executive Leadership • Hybrid Reports To Chief Executive... ..., customer services & provider network management Regulatory and contractual compliance across Medicaid managed care requirements...
Suggested
Contract work
Work at office
Local area
Southwest Michigan Behavioral Health
Portage, MI
9 days ago
Principal Regulatory Affairs Specialist, (Hybrid)
$126.5k - $210.7k
...Flexibility: HybridJoin Stryker's Instruments Division as a Principal Regulatory Affairs Specialist, where you will serve as a key regulatory expert... ...for product development, commercialization, and lifecycle management activities.Collaborate with cross-functional partners to...
Suggested
Full time
For contractors
Stryker
Portage, MI
1 day ago
Chief Credit Officer (CCO)
...executive will be responsible for all aspects of credit risk management, portfolio administration, asset quality, and underwriting across... ..., developing and maintaining credit policies, and ensuring regulatory compliance. The successful candidate will also be tasked with...
Suggested
Confidential
Kalamazoo, MI
3 days ago
Senior Director, Corporate Ethics and Compliance
$174.88k - $233.17k
...function. The Main Responsibilities Develop, implement, and maintain comprehensive ethics and compliance and compliance risk management program aligned to the Corporate Sentencing Guidelines. Oversee internal whistleblower hotline, prepare quarterly reporting...
Suggested
Full time
Temporary work
Lumen
Kalamazoo, MI
2 days ago
Survey Crew Chief
Job Title: Survey Crew Chief Position Overview: The Survey Crew Chief leads a field survey crew and is responsible for the accurate and efficient execution of surveying tasks. This role requires strong technical knowledge, leadership in the field, and the ability to work...
Flexible hours
Hurley & Stewart
Kalamazoo, MI
4 days ago
Survey Crew Chief
Survey Crew Chief I am partnered with a Civil Engineering and Land Surveying firm and they are looking to add a Survey Crew Chief to their growing team! Minimal local travel. What you will be doing: Field and office work for construction staking, topographic, ...
Work at office
Local area
gpac
Kalamazoo, MI
2 days ago
Survey Crew Chief
...performing topographic, construction staking, boundary surveys and control surveys using both conventional and GPS techniques Managing survey project and meeting project deadlines and budgets. Performing office calculations and support field survey crews for construction...
Work at office
Local area
Flexible hours
Impact Recruitment
Kalamazoo, MI
2 days ago
Executive Director
...the Executive Director, you will be responsible for the overall management, strategic direction, and day‑to‑day operations of the... ...family services, resident well‑being, quality assurance, and regulatory compliance. Develop a thorough working knowledge of state...
Local area
Flexible hours
Weekend work
Afternoon shift
Parallel Corporate
Kalamazoo, MI
2 days ago
Executive Director
$175k - $195k
...a visible ambassador for the holistic defense model. The organization seeks a collaborative and strategic leader with executive management experience, a strong understanding of the criminal legal system and its impact on individuals and communities, and a demonstrated...
Full time
State Bar of Michigan
Kalamazoo, MI
4 days ago
Executive Director
The Opportunity For nearly 30 years, the Stryker Johnston Foundation (SJF) has been investing in leaders, organizations, and groups who are making an impact in Kalamazoo, Michigan. SJF has established a strong reputation for impact and respected trust-based grantmaking...
Stryker Johnston Foundation
Kalamazoo, MI
5 days ago
Healthcare Facilities Operations Director - Sustainability & Compliance
...operational plans, drive efficiency, and ensure compliance with regulatory standards across the hospital campus. The role requires... ...leadership, deep knowledge of MEP systems, and a proven track record in healthcare facilities management. #J-18808-Ljbffr Jobleads-US
Jobleads-US
Kalamazoo, MI
15 hours ago
Executive Director
...fundraising, external relations, and operational oversight. This role requires a collaborative and strategic leader with executive management experience, a strong understanding of the criminal legal system and its impact on individuals and communities, and a demonstrated...
Confidential
Kalamazoo, MI
4 days ago
Executive Director
...underserved children & youth in BiH Industry International Affairs Type Non Profit Founded 2000 Employees 1-10... ...team leadership and mentorship, board partnership, financial management, public relations, and strategic planning for national expansion...
Local area
Confidential
Kalamazoo, MI
1 day ago
Director, Life Sciences - Oligo & Peptide Market Segment Leader
...mentoring development programs, identifying strategic market hires, and growing the SME and A&C reviewer network. Growing CRB’s market regulatory expertise. Being the market face of CRB for engagement with global regulatory bodies and industry lobby groups. Support...
CRB
Kalamazoo, MI
3 days ago
Associate Manager, Sustaining Sourcing
$89.3k - $148.8k
Work Flexibility: HybridPosition Summary:The Associate Sourcing Manager is responsible for developing and executing strategic sustaining sourcing initiatives that drive cost, quality, service, and supply continuity improvements. This role partners with suppliers and cross...
Full time
Contract work
For contractors
Work at office
Stryker
Portage, MI
2 days ago
Inbound Member Relationship Officer (Located in Portage, MI)
...experience in a fast paced, sales driven role required. ~ Previous lending experience preferred. ~ Must be highly organized and able to manage a high level of loan activity. ~ Must be friendly, energetic, & professional. ~ Excellent analytical, communication, and...
Work at office
Remote work
Kalsee Credit Union
Portage, MI
6 days ago
President (of 4-School Network)
The Opportunity A defining moment for Catholic education in Kalamazoo The Catholic Schools of Greater Kalamazoo (CSGK) seek a visionary President to serve as Chief Executive Officer of a newly unified, county-wide Catholic school system. A family of schools since 2004...
Full time
Catholic School of Greater Kalamazoo
Kalamazoo, MI
4 days ago
Principal, IT Strategy & Operations Manager
$152.07k - $202.76k
...impact, and help shape the future of AI‑ready connectivity, join us today. The Role The Principal, IT Strategy & Operations Manager is a senior individual-contributor role that partners with Technology VPs, Finance, business leaders, and external partners to shape...
Full time
Contract work
Temporary work
Work at office
Remote work
Lumen
Kalamazoo, MI
2 days ago
Senior Manager, Business Development Strategic Planning (hybrid)
$135.6k - $225.9k
Work Flexibility: Hybrid or OnsiteAs the Senior Manager, Business Development Strategic Planning, you will play a leadership role in the Instruments Division’s annual strategic planning process by setting vision for the Strat Planning process, managing deliverables, organizing...
Full time
For contractors
Work at office
Stryker
Portage, MI
1 day ago
Director of Hospitality Sevices
Job Description Job Description This job is posted on behalf of Welsh & Associates, Inc. by Top Echelon. Elevate Culinary Standards. Lead Hospitality. Director of Hospitality Services Opportunity Overview: In senior living, dining is far more than a routine...
Night shift
Weekend work
Welsh & Associates, Inc.
Kalamazoo, MI
4 days ago
REMOTE BENEFITS MANAGING DIRECTOR
...-Explain options in a clear, simple, and relatable way -Help clients complete online enrollment forms accurately -Schedule and manage virtual appointments -Use basic computer skills (email, Zoom, online systems) daily -Follow a proven process with training and...
Remote job
Full time
Zuzick Organization of Globe Life
Kalamazoo, MI
15 hours ago
Chief Growth Architect
Bodwé, the Professional Services Group of the Pokagon Band, seeks an Executive Vice President, Growth to lead enterprise growth across Bodwé companies, markets and service lines. You will oversee strategy, client development, pipeline, capture, proposals, and the transition...
Jobleads-US
Kalamazoo, MI
2 days ago
Quality Assurance Specialist
$70.5k
...has had experience with external suspicious activity reporting, regulatory compliance and FIUs. Activities performed on the job... ...data as appropriate. Systems and Tools: Competent using case management systems, dashboards, AI tools to support case working and analysis...
Eurofins USA BioPharma Services
Portage, MI
1 day ago
Head of Recruiting & HR
...talent. Oversee compensation and benefits programs, including management of grant-funded salary structures. Direct employee... ...COMPETENCY AREA KEY SKILLS & KNOWLEDGE PROFICIENCY LEVEL Regulatory Compliance HRSA, FTCA, HIPAA, FMLA, ADA, EEO, OSHA,...
Family Health Care Center Of Kalamazoo
Kalamazoo, MI
1 day ago
Head of Recruiting & HR
...HUMAN RESOURCES MANAGER - We Serve. We Grow. We Achieve. MISSION: To provide clinical excellence with outstanding patient experience while ensuring that all members of the community have access to quality, comprehensive, patient-centered health care. COMPANY...
Family Health Care Center Of Kalamazoo
Kalamazoo, MI
1 day ago
Head of Recruiting & HR
$85k - $100k
...HR Manager Location: Kalamazoo, MI Industry: Manufacturing Schedule: Full-Time | Monday-Friday Compensation: $85,000 - $100,000 annually HR Manager Opportunity Our client, a growing and highly respected manufacturing company in Kalamazoo, MI, is seeking...
Full time
Local area
Monday to Friday
Creative Financial Staffing
Kalamazoo, MI
2 days ago
Sr. Quality Management System Specialist
$72.5k - $120.9k
...The Senior Quality Management System Specialist will help design, maintain, and continuously improve a quality management system that supports regulatory approval and business growth across global markets. You’ll collaborate across functions to ensure quality processes...
Full time
Stryker
Portage, MI
15 days ago
Executive Vice President, Growth
...procurement, construction, and operations. By integrating expertise across architecture, engineering, construction, and facility management, we deliver holistic, end-to-end solutions that drive efficiency and deliver distinctive outcomes. Position Summary The Executive...
Contract work
For contractors
Jobleads-US
Kalamazoo, MI
2 days ago
Aviation Officer
...territory or dropping bombs from the backseat of an F-18 fighter jet. AVIATION MAINTENANCE DUTY OFFICER - You’re in charge of managing the repair and upkeep of our most lethal aviation assets—over eighty different types of aircraft. In addition to that, you manage...
Part time
U.S. Navy
Kalamazoo, MI
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Manager, Regulatory Affairs. Be the first to apply!