Job Title:
Director, Regulatory Affairs

Req #:
3902BR

Job Description:
Provide leadership for the Vision Care Regulatory Affairs team relative to developing and executing regulatory submission strategies for the Vision Care (Lens and Lens Care Solutions) portfolio on a global, regional and country level. Train, develop and supervise regulatory personnel who provide support to the Vision Care business unit. Assure tactical objectives are achieved which include US and non-US submissions, label and advertising review, removals and corrections support as well as recommend and implement procedural improvements. Assure timely regulatory clearances for new products as well as assure existing marketing authorizations are maintained. This will require knowledge and oversight in the preparation of US and non-US submissions that include but are not limited to , IDE, 510(k), PMA, PMA Supplements, Technical Files, Establishment Registration and Device Listing. Lead and develop Vision Care Regulatory Affairs competencies which include hiring, managing performance, creating and executing development plans for team, and product skills development training within the team. Challenge project team members and regulatory staff to seek alternate solutions, raise performance standards, and partner well with key internal customers such as marketing and R&D. Contribute to an environment that fosters collaboration, trust, regulatory and scientific excellence, creativity and proactive behavior.. Provide input to global regulatory strategy development and implementation to achieve complete regulatory submissions in a timely and cost effective manner. Review, approve and provide guidance for labeling and advertising of B&L device products. Counsel technical and business groups to establish direction based on available data and regulatory considerations. Interact with US and non-US government officials on compliance issues in a manner that establishes, and maintains credibility to bring any issues to successful resolution. Review and approve department policies and procedures Provide review and guidance of failure Investigations and corrective actions referred to Regulatory Affairs. Provide guidance on regulatory compliance. Provide input and comment to regulations and standards which may affect B&L device products

Qualifications
BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law. Advance degree or additional professional training desired. 10+ years of Medical Device or Pharma Industry Experience with a minimum of 7 years experience in Regulatory Affairs with a demonstrated capability and experience managing people, driving process and managing projects. Demonstrated effectiveness interacting with internal and external constituents throughout the product lifecycle. Knowledge of medical device or drug GMP's important. Management Competencies: Demonstrated knowledge and skill in submission strategies as well as overall Regulatory Science. Demonstrated experience in leading a team and carrying out performance management and talent processes. Ability to partner, negotiate, and drive towards win/win outcomes. Develops effective global internal/external relationships (e.g. cross category, cross functional, etc.) Excellent oral communication skills (command of English language) and technical writing skills. Ability to effectively present information in one-on-one and small group situations to internal customers and other employees of the organization. Ability to communicate well with all levels of the organizations. Technical Competencies: Strong questioning and problem-solving skills. Mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions. Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures. Ability to write routine reports and business correspondence. Computer literate with general office software and internet use.

Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes

Status Full-Time