Senior Manager Medical Devices/IVD
2 months ago
We are currently looking for an experienced Senior Manager to support our Regulatory Affairs Team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude, and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
PharmaLex is proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.
Key Responsibilities and Activities
- Accountable for the execution of projects in the field of regulatory, technical, and quality management consulting predominantly in the medical device and diagnostic sectors.
- Support more senior colleagues with their client-related work and assist junior colleagues as required.
- Support the organization with any relevant operational needs.
- Advising, supporting, managing regulatory, technical, and quality management consulting projects for clients in the medical devices and diagnostic sectors.
- Supporting PharmaLex staff and their customers in the implementation of medical devices and diagnostic regulatory strategies.
- Ensuring optimal licensing for marketing and regulatory compliance of complex products.
- Preparing, revising, and compiling product information for clients (e.g. IFUs, PIL, labels).
- Creating, revising, editing, and maintaining technical dossiers and regulatory documentation for clients.
- Preparing and participating in Scientific Advice Meetings with regulatory authorities.
- Preparing and presenting seminars and lectures within their area of expertise to PharmaLex-internally and to clients and professional audiences.
- Communicating with the client and the Health Authorities within area of expertise (e.g. jurisdiction, process, or product).
- Training and mentoring less experienced colleagues in consulting practices, regulatory frameworks and in client project work.
- Contributing to the optimization of departmental internal processes.
- Actively contributing to the sharing of knowledge within the Medical Device / IVD department.
- Participating in strategic regulatory issues (e.g. Regulatory consultations).
- Supporting the preparation, quotation, and invoicing o of Projects in close cooperation with the respective Project Lead.
- Providing support to more senior colleagues in complex or strategic client-related work, including representation at business development meetings, conferences and in marketing activities.
Without checking with your supervisor
- Day-to-day client interaction and project portfolio management
- Delivering consultancy services as per agreed Statement of Works (e.g. regulatory research, report compilation, technical advice)
- Identifying next project steps with Clients and participating in the establishment of relevant Statements of Work
- Directly managing service delivery within the project scopes, budgets and raising project risks to supervisor
- Supporting junior and senior staff with their project work
- Readily sharing knowledge in relevant technical disciplines (e.g. Regulatory, Quality Assurance and technical fields)
- Suggesting Quality System modifications, document revisions and internal audit
- Supporting internal Quality System activities (e.g. CAPAs, Audits) as per operational needs
- Attending or participating in conferences, industry working groups and consultations, etc.
- Assisting with the preparation and delivery of training sessions
- Initiating new client contacts
- Releasing new Statements of Work to Clients
- Conducting business development activities and other significant business-related activities
- Delivering business-critical advice to clients (e.g. commercial & compliance strategies)
- Acting on new business development and marketing activities
- Releasing high value client reports
- Raising opportunities related to business operations, service promotion and structure.
- Recommending staff development needs
- University degree in Science or Engineering
- 6 + years in regulatory and/or quality management in medical device, diagnostics, biotechnology, or related consulting environment.
- Hands-on experience in the preparation of regulatory and technical submissions, reports, and documentation or in the implementation of quality management systems (e.g. ISO 13485, ISO 9001, 21 CFR 820, MDSAP or equivalent), preferably in the medical device or diagnostics environment.
- ASQ/Exemplar Global Certified Auditor is a plus.
- Regulatory Affairs Certification from RAPS is plus.
- Sound understanding of local and international regulatory and compliance legislation and requirements.
- Ability to efficiently obtain and review information from a range of sources.
- Ability to interpret, analyse, plan, write and apply appropriate legislation, regulatory, technical, and quality requirements.
- Ability to identify and understand the commercial context of Clients and make project decisions accordingly.
- Ability to prepare regulatory documents and reports that are accurately referenced, with appropriate citation and written in cohesive manner to optimise outcomes.
- Identify up selling opportunities within their project portfolio.
- Complex problem-solving abilities, strong understanding of the consulting business
- Structured, analytical, systematic, and independent approach to work
- Team player with collaborative work style and willingness to knowledge share
- Client orientation
- Effective written and spoken communication skills with internal and external customers, colleagues and supervisors.
- Flexible and adaptable
- Experienced user of the MS-Office package, Adobe Acrobat, and database systems
- English and Spanish language fluency, written and spoken.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
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