Director, Regulatory Affairs - (US-NY-Rochester)

Director, Regulatory Affairs - (US-NY-Rochester)

Compensation: $110K - $140K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: B3902BRJA

If not you, would you know someone???  I will pay a finders' fee if you refer someone who is hired.

Experience Required : 10 + years
Degree Required : 4 Year Degree
Travel Required : to 25%
PAID RELOCATION AVAILABLE

Provide leadership for the Regulatory Affairs team relative to developing and executing regulatory submission strategies for the region and country level.
Train, develop and supervise regulatory personnel who provide support to the 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 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.

Computer literate with general office software and internet use.

Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.

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Jeff Altman, The Big Game Hunter
Concepts In Staffing
9 East 37 Street
New York, NY 10016

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