Regulatory Affairs Director
7 days ago
Job Summary:
Medicomp Inc is seeking a highly experienced Product Development Director to lead our New Product Development (NPD) function. The successful candidate will be responsible for facilitating the achievement of new product development objectives, new product commercialization objectives, and overall enterprise strategic business objectives.
Key Responsibilities:
- Direct NPD project execution for all Medicomp North American product lines and business initiatives.
- Lead and manage NPD department resources to support achievement of business objectives.
- Oversee NPD departmental budget.
- Manage execution of deliverables in support of phase-gate design-controls NPD project plans to support business objectives.
- Ensure NPD project deliverables comply with applicable regulatory standard requirements including FDA QSR, ISO 13485, CDC NIOSH and EU MDR requirements.
- Manage and facilitate compliant, efficient and risk-based execution of phase-gate design controls NPD project deliverables, NPD engineering deliverables, new product development plans, coordinate verification and validation testing, provide inputs into regulatory planning process, manage execution of documentation to support compliance with design controls process including medical device design history files.
- Assist product development project portfolio management to assure portfolio continuously aligns with commercial strategy and available resource capacity/capability with objective and stable prioritization.
- Determine and drive implementation of NPD strategy and roadmap.
- Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures.
- Drive NPD process improvements and updates using continuous improvement approach.
- Facilitate achievement of business objectives using risk-based approach while ensuring compliance within the flexibility of the regulations.
- Lead high-performing team to support NPD functional objectives; facilitate organizational cohesiveness with the Medicomp R&D operating model, business strategy and culture of quality and compliance.
- Drive efforts for design history file and/or related quality system or regulatory requirement remediation activities if necessary.
- Lead inspections and audits of design control documentation by applicable regulatory agencies including FDA, NIOSH and notified body.
- Manage execution of documentation control process tasks to support implementation design control process controlled documentation.
- Drive continuous improvement of design controls process, quality system and documentation processes to support business objectives.
Requirements:
- Bachelor's Degree in engineering, life sciences, quality/regulatory or related technical discipline.
- 10+ years experience with progressive increasing management responsibility within regulated medical device NPD/R&D and/or life sciences discipline.
- Travel domestically and internationally as required by business objectives, anticipated to be less than 25% of-time.
- Master's degree and/or professional certification in scientific, engineering related technical discipline.
Equal Opportunity Employer:
Medicomp Inc is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.
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