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Senior Regulatory Affairs Consultant
2 months ago
Recruiter:
Spencer Gregory Hale
Position Overview:
The Principal Regulatory Affairs Specialist plays a crucial role in enhancing and streamlining regulatory product approval workflows. This position serves as a key Regulatory Affairs representative within the domains of Material Controls, Supplier Quality, and Medical Electrical Equipment.
Moreover, the Specialist is tasked with advocating for regulatory considerations during quality system projects, process modifications, and audit support.
Key Responsibilities:
Act as the Regulatory Affairs Lead on initiatives aimed at transforming the approach to capital equipment life cycle management within the quality system, covering aspects from part creation, labeling, and testing to distribution and servicing.
Engage with cross-functional teams, particularly in Supplier Quality, Material Controls, and Design Controls, to provide the regulatory perspective and develop innovative compliance solutions in the areas of Medical Electrical Equipment, Material Controls, and Supplier Quality.
Proactively guide global site and divisional partners in understanding new regulatory concepts and requirements, promoting the adoption of Best Practices.
Collaborate with team members across divisions and regulatory affairs to pinpoint process inefficiencies and opportunities for improvement.
Identify and initiate projects to address specific needs within the medical equipment sector, establishing business cases as necessary.
Participate actively in various Quality System Community of Practice teams, representing Regulatory Affairs interests and assessing impacts.
Engage in advocacy efforts to stay informed on regulatory trends and expectations, benchmarking against industry leaders.
Draft, revise, and edit standard operating procedures and work instructions.
Serve as the Regulatory Affairs Subject Matter Expert in evaluations of global regulatory changes, working with cross-functional teams to influence necessary adjustments to the quality system.
Coordinate regulatory strategies and execute deliverables to facilitate the implementation of manufacturing process changes affecting multiple divisions.
Contribute to the training and mentoring of team members.
Engage in departmental systems development initiatives.
Required Qualifications:
Minimum of a Bachelor's degree
At least 5 years of experience in Regulatory Affairs or a related field (e.g., Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical, or healthcare sectors
Familiarity with FDA, EU, and/or international medical device regulations
Experience with audits from regulatory authorities (e.g., MDSAP and ISO 13485)
Ability to interpret global regulations and standards
General understanding of product development processes, design controls, and quality system regulations
Proficiency in Microsoft Office applications (Teams, Word, Excel, PowerPoint)
Preferred Qualifications:
Degree or work experience in a scientific or technical field
Experience managing complex organizational structures and demonstrated ability to collaborate and influence across such environments.
Exceptional written and verbal communication, technical writing, and editing skills
Strong research and analytical capabilities
Ability to manage multiple projects concurrently
High sense of urgency and commitment to execution.
Proven leadership, collaboration, and influencing abilities
Willingness to travel to various divisions and corporate headquarters (estimated 10% travel in non-pandemic conditions)
This role is classified as safety-sensitive, and candidates will be subject to a prohibited substance test as a requirement.
