Staff Regulatory Affairs Spec - Software & digital health
Location
Andover, Hampshire | United Kingdom
Job description
Staff Regulatory Affairs Spec - Software & digital health page is loaded
Staff Regulatory Affairs Spec - Software & digital health
Apply locations USA MA - Andover time type Full time posted on Posted 4 Days Ago job requisition id R21-00605437
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn , Facebook , Instagram and Twitter .
The Staff Regulatory Affairs Specialist - Software & digital health will be creating and carrying out global regulatory strategies and objectives for embecta. This includes a focus on new digital health/software product introductions, modifications to existing products, and related activities, such as development, execution and management of procedures and systems crafted to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
RESPONSIBILITIES:
- Provides leadership to assigned digital health/software project teams throughout its product lifecycle to achieve worldwide clearance/approval/registration in alignment with business objectives.
- Assesses regulatory pathways for marketing new and modified products containing software; Develops associated strategies and tactical plans for submissions to FDA, EU Notified Body and other agencies.
- Identifies and communicates risks and mitigations associated with regulatory strategies to cross-functional partners.
- Prepares, or directs the preparation of submissions (Pre-Meetings, PreSubs, PMAs, 510(k) s, Technical Files/Documentation, and documentation for ex-U.S. registrations).
- Represents embecta in interactions/negotiations with U.S. and global regulatory agencies.
- Participates in trade associations, policy and advocacy efforts to assigned products and platforms such as Software and Cybersecurity Industry working groups.
- Reviews and approves labels, labeling, promotional materials, clinical protocols/reports.
- Monitors ongoing regulatory intelligence/developments affecting embecta development programs and communicates emerging opportunities and concerns to partners (e.g. supervisor, Leadership Team and Project Teams).
- Ensures compliance with and contributes to the optimization of regulatory departmental policies, procedures, and records in accordance with applicable regulations and standards.
- Collaboration with development team in Andover, MA will require availability for minimum of 10% travel.
EXPERIENCE & EDUCATION:
- B.S. or B.A. degree in a technical subject area (e.g., engineering, biology, chemistry). Advanced degree preferred.
- Minimum five years of directly related professional regulatory experience with software products in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields.
- Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Experience leading meetings and negotiating with FDA personnel in the device (CDRH) areas and other global Health Authorities.
- Proven success in the strategy development, preparation, and authoring of regulatory submissions (PreSub, PMA, 510(k), IDE) and correspondences to FDA and other global regulatory agencies.
- Experience working with standalone software, software as medical device (SaMD), Artificial Intelligence, and Machine Learning.
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrated project management, negotiation, and excellent communication (written and oral) skills.
- Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
- Demonstrated global perspective, customer focus, cross-functional collaboration.
- Comprehensive knowledge of US and European software medical device regulations, Good Clinical Practice Standards, Good Laboratory Practices, and Quality System Regulation.
- Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Experience in negotiating with FDA personnel in the device (CDRH) and biologics (CBER) areas.
- Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies.
- RAPS Certification and/or ASQ certification in Auditing.
embecta is an Equal Opportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
About Us
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn , Facebook , Instagram and Twitter .
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