Quality and Regulatory Specialist - Americas

Quality & Regulatory Specialist - Americas

Norcross, Georgia (US)

Grow your career in a role that truly matters

At Molnlycke, we help healthcare professionals improve patient outcomes every day. As a Quality & Regulatory Specialist - Americas, you'll play a critical role in ensuring our products meet the highest standards of safety, quality, and compliance across the region.

This is an exciting opportunity to work at the intersection of regulatory strategy, quality systems, and product innovation, partnering with teams across the Americas and globally. It's also a fantastic role for someone with strong foundational experience who is eager to grow, learn, and develop into a QARA subject matter expert over time.

What you'll do:

As a key member of our QARA team, you will:

• Support regulatory activities across the United States and Canada, while contributing to Quality Management System (QMS) initiatives in LATAM
• Assist in the development and execution of regulatory strategies for new and modified products
• Prepare and support regulatory submissions (e.g., FDA 510(k), NDA supplements, Health Canada submissions)
• Act as a point of contact with regulatory authorities, including exposure to direct interaction with the FDA
• Partner cross-functionally with R&D, Operations, and Commercial teams to ensure regulatory compliance
• Support and continuously improve the Americas Quality Management System, aligned with FDA QSR, ISO 13485, and MDSAP
• Contribute to CAPA activities, non-conformance investigations, and field actions/recalls as needed
• Help strengthen document control and training processes, ensuring accuracy and compliance
• Collaborate across regional and global teams, including close interaction with our global HQ in Sweden

You'll play an important role in increasing team flexibility-supporting teammates, learning processes across QA and RA, and building a well-rounded QARA skillset.

What you bring:

We're looking for a curious, proactive, and detail-oriented professional who thrives in a collaborative, fast-paced environment and is motivated to grow.

Required qualifications:

• Bachelor's degree in a relevant scientific or technical field
• Experience in Quality Assurance and/or Regulatory Affairs within a regulated industry (medical device or pharma preferred)
• Working knowledge of FDA regulations, ISO 13485, and quality systems
• Strong attention to detail and ability to deliver work accurately and on time
• A continuous learning mindset with the willingness to develop new competencies
• Ability to work effectively as a team player in cross-functional environments
• Comfort using digital tools, systems, and emerging technologies (including AI tools)

Preferred:

• Experience with FDA and/or Health Canada submissions, including 510(k) exposure
• Familiarity with CAPA, non-conformance processes, or document control systems
• Experience supporting LATAM regulatory or quality requirements

Compensation & Benefits:

Offers of employment considervarious factors, including experience, education, location, and role-specific requirements.

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 lifestyleperkslike discounted access to entertainment and travel.

Our Approach to Diversity & Inclusion

We're building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve. Inclusion isn't just a value, it's how we work, grow, and lead together.

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 in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalization are at the heart of everything we do.

Molnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Molnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health.