Compliance Manager overseeing regulatory audits and compliance projects at Elevance Health. Ensuring adherence to regulations and managing audits while collaborating with various stakeholders.
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
Job title
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Not specified
Degree requirement
Location requirements
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