Essential Competencies + Skills:
Education: Bachelor’s degree preferred.
Work Experience: A minimum of 3 years of regulatory work experience in a regulated industry or one year of regulatory experience coupled with a master’s degree in a regulatory program.
Preferred Experience: Experience in regulations and standards applicable to Medical devices (predominately Class 1), cosmetics, dietary supplements, over-the-counter (OTC), children’s products, and consumer goods. A working knowledge of 21 CFR 820 and ISO 13485. Experience with Medical Device Directive/ Medical Device Regulation. Experience in preparing technical files for CE marked products. Experience in preparing 510k submissions. Internal quality auditing experiences.
Travel Requirement: Less than 10%.
Critical skills and abilities:
- Proven ability to develop and execute practical and cost-effective regulatory strategies to ensure that applicable regulatory requirements are satisfactorily met. This includes new products, and expansion of existing products into new markets.
- Ability to translate regulatory strategies into specific objectives and practical and cost-effective operational plans to achieve competitive advantage.
- Ability to interpret regulatory requirements to support sales of products into global markets, and working with other functions in the company to implement effective systems to meet these regulatory requirements (including technical documentation, foreign language labeling, and any premarket approval or registration requirements).
- Ability to provide overall direction for all regulatory affairs activities and adapt approach to match the needs of different individuals and teams.
- Working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures.
- Knowledge of product liability issues associated with medical device industry.
- Knowledge and understanding of company products as they relate to medical device law and international medical device requirements.
- Ability to negotiate critical points regarding devices to the favor of corporate objectives, (e.g. to reduce costs associated with regulation and/or marketing objectives).
- Knowledge and ability to review and approve technical literature, technical files and product specifications and ensure that these are consistent with domestic and international regulations.
- Effective leadership and team facilitation skills to motivate cross-functional staff to deliver information related to submission preparation and/or direct technical and sales marketing product literature review.
- Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.
- Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills.
- Proven ability to cultivate an active network of relationships within and outside of the organization.
- Knowledge of basic and advanced reliability, fault analysis, and product benchmarking techniques. Knowledge of basic and advanced design techniques such as robust design, design of experiments, quality function deployment, process capability, qualification, validation, and design review.
- Financial knowledge and experience to understand key financial indicators for the division as well as the company and to evaluate strategic opportunities.
No agency calls at this time.