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Principal Regulatory Affairs Specialist
1 month ago
Principal Regulatory Affairs Specialist
About the role:
The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces. Additionally, the Associate is responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support.
Your responsibilities will include:
- Perform as the Regulatory Affairs Lead team member on initiatives to transform how we address the unique needs of capital equipment life cycle within the quality system (from part creation, labeling and testing to distribution and servicing).
- Collaborate with cross functional partners (specifically Supplier Quality, Material Controls and Design Controls) as the Voice of Regulatory to deliver innovative solutions for achieving and maintaining compliance in the areas of Medical Electrical Equipment, Material Controls, Supplier Quality, and others.
- Proactively influence global site and divisional partners and leadership in interpretation/understanding of new concepts and requirements and adoption of Best Practices. In addition, working to ensure understanding and translation of strategies, goals and the full scope of Business Transformation initiatives.
- Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for process efficiencies.
- Identify, establish business cases for, initiate and lead projects to address needs within the medical equipment space.
- Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams.
- Actively participate in advocacy streams to get a pulse on regulation trends and expectation as well as benchmark against other industry leaders (current areas for connection include repair, cybersecurity, and others).
- Author, revise and edit standard operating procedures and work instructions.
- Participate as the Regulatory Affairs SME in assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed.
- Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions.
- Participate in training and mentoring of staff.
- Participate in department systems development initiatives.
- Minimum of a Bachelor's degree
- Minimum of 5 years' experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
- Working knowledge of FDA, EU and/or international medical device regulations
- Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
- Ability to read and interpret global regulations and standards
- General understanding of product development process, design controls and quality system regulations
- Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)
- Degree or work experience in a scientific or technical discipline
- Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization.
- Excellent written and oral communication, technical writing and editing skills
- Excellent research and analytical skills
- Ability to manage multiple projects simultaneously
- High sense of urgency and commitment to execution.
- Proven leadership, collaboration and influencing skills
- Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions)
Requisition ID: 588395
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
