Director, Commercial QARA – Americas

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<div class="isg-job-description“>Director, Americas Commercial QARA

Location: Metro Atlanta

At Molnlycke, we’re on a mission to advance performance in healthcare. As a global leader in medical solutions, our products and services enhance the lives of patients and professionals in over 100 countries. We’re growing fast-and we’re looking for bold thinkers, expert problem-solvers, and strategic leaders to grow with us.

We’re seeking a Director, Americas Commercial QARA to lead our regional Quality and Regulatory Affairs strategy across the Americas.

This role is part of the Global QARA Commercial Leadership team and will be instrumental in ensuring compliance, driving continuous improvement, and supporting business growth through strategic leadership in QARA. The ideal candidate brings deep expertise in regulatory frameworks, quality systems, and cross-functional collaboration, along with a passion for building scalable processes and mentoring high-performing teams.

What You’ll Do:

• Lead and develop the QARA Commercial Americas team to support regional growth and strategic goals.
• Ensure compliance with internal and external regulatory requirements, standards, and policies.
• Develop and execute sustainable regulatory pathways and product registration roadmaps.
• Collaborate closely with commercial leaders and global QARA teams.
• Provide Global R&D and local Commercial teams with critical guidance on product submission strategy in the US and broader Americas Region, serving as the liaison to FDA during pre-submissions and approval phases.
• Oversee regulatory filings, product certifications, and incident reporting across the region.
• Manage external audits and inspections, and lead corrective actions as needed.
• Maintain and improve local quality management systems and ensure alignment with global processes.
• Direct liaison with regulatory agencies to negotiate pathways and ensure optimal outcomes.
• Oversee regional cost centers and manage total functional costs for QARA Commercial Americas.

What We’re Looking For:

• Bachelor’s degree in life sciences or a relevant scientific discipline; advanced degree preferred.
• Minimum of 10 years in an international medical device company, with at least 5 years in a leadership role within QA and/or RA.
• Deep understanding of regulatory requirements in the Americas, including ISO 9001, ISO 13485, MDR, and regional standards.
• Pharma & Med Device experience within QA/RA
• Proven ability to lead cross-functional teams and work with internal stakeholders, including sales, marketing, and finance.
• Excellent communication, negotiation, and stakeholder management skills.
• Experience with distributor agreements, tenders, and sales quality processes.
• Fluent in English; Spanish fluency is a plus.

Compensation & Benefits:

Offers of employment consider various factors, including experience, education, location, and role-specific requirements. Beyond competitive pay, Molnlycke Health Care offers comprehensive benefits and fosters a supportive, inclusive culture that prioritizes employee well-being and professional growth. Join us and experience a workplace where your contributions are valued and your career can thrive!

Our comprehensive benefits package is designed to support your health, financial well-being, and work-life harmony:

• Medical, dental and vision plans are available from your first day of employment, and provide extensive coverage through multiple options so you can find the right fit for you and your family.
• Financial benefits include a robust 401(k) plan with company match, profit sharing, tuition reimbursement, life insurance and both flexible spending accounts and health savings accounts.
• Molnlycke offers generous paid time off, paid parental leave, an Employee Assistance Program and lifestyle perks like discounted access to entertainment and travel.

Our approach to diversity and inclusion:

At Molnlycke, diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced and every employee, regardless of background or any other traits, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role.

About Molnlycke:

Molnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organized into four business areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics. Customer centricity, sustainability, and digitalization are at the heart of everything we do.

Molnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden, and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which were founded by the Wallenberg family in 1916.

It is the policy of Molnlycke Health Care, in accordance with all applicable laws, to recruit, hire, train, and promote persons in all job titles without regard to race, color, national origin, genetic information, religious beliefs, sex, gender identity, sexual orientation, age, marital status, pregnancy, disability, protected veteran status, or any other protected classifications, activities, or conditions as required by federal, state and local laws.

 

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