Hybrid Senior Staff Specialist, Regulatory Affairs

at Stryker

• Job title: Senior Staff Specialist, Regulatory Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Selzach, Switzerland

About the role

• Senior Staff Specialist driving regulatory strategy across the product lifecycle at Stryker. Partnering with cross-functional teams to ensure compliance with global regulatory requirements.

Responsibilities

• Serve as a technical expert and strategic advisor within Stryker’s regulatory organization.
• Drive regulatory strategy across the product lifecycle and partner closely with cross-functional teams.
• Provide deep expertise, influence key decisions, and help shape successful pathways for global market access.
• Develop and evolve regulatory strategies by assessing regulatory intelligence, emerging trends, and changes in global requirements.
• Advise R&D, Quality, Clinical, and Marketing teams throughout the product lifecycle to ensure regulatory compliance.
• Evaluate product concepts, classifications, and regulatory pathways to identify opportunities, risks, and solutions for timely market access.
• Negotiate with regulatory authorities and lead interactions throughout product development, submission, and review.
• Prepare, submit, and track global regulatory submissions in alignment with regulatory guidelines and internal quality standards.
• Assess the impact of proposed clinical, manufacturing, or product changes and recommend regulatory filing strategies.
• Support the development and implementation of new or updated SOPs, processes, and guidance documents to ensure compliance.
• Train and mentor stakeholders on regulatory requirements, expectations, and best practices to enhance organizational capability.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum 6 years of regulatory affairs experience in medical devices or another highly regulated industry.
• Strong knowledge of global regulatory pathways, submission requirements, and product lifecycle management.
• Experience developing regulatory strategies and interacting with regulatory authorities.
• Ability to analyze complex information, exercise sound judgment, and propose actionable solutions.
• Strong communication, collaboration, and stakeholder-influencing skills.
• Ability to manage multiple priorities and operate independently with sound decision-making.
• Master’s degree in Regulatory Science or related field (preferred).
• Regulatory Affairs Certification (RAC) (preferred).
• Experience supporting premarket submissions, post-market activities, and global registrations (preferred).
• Familiarity with clinical investigations, pre-approval inspections, and postmarketing surveillance (preferred).

Benefits

• Flexible working hours model
• Opportunity to work partially from the home office