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Regulatory Affairs
Ref No.: 18-13280
Location: Bridgewater, New Jersey
Position Type:Contract
Start Date / End Date: 09/17/2018 to 09/16/2019
Sunrise System Inc. is currently looking for Regulatory Affairs in Bridgewater, NJ with one of our top client.
Job Title: Regulatory Affairs
Job Id: 18-13280
Location: Bridgewater, NJ 08807
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • Plans and prepares complex medical device regulatory submission documents for US, Canada, and EU regulatory filings.
  • Provides support for other global regulatory filings.
  • Utilizing detailed, in-depth understanding of medical device regulations, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance.
  • Supports management with regulatory programs planning and implementation of departmental strategies and policies. 
Key duties and responsibilities: describe scope:
  • Submissions, development and lifecycle maintenance:
  • Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision.
  • Resolves submission problem areas with team.
  • Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision.
  • Prepares complex expository and technical documents, logically constructed and comprehensive in content.
  • Prepares documentation that is complete, accurate, and on time.
  • Manages post-approval projects not requiring a global core team.
  • Approves manufacturing process changes as appropriate. Plans and implements regulatory activities that support lifecycle management (e.g. Clinical Evaluation Report support, annual reports, changes, etc.)
  • Reviews labelling and packaging components to ensure accuracy and compliance with government regulations.
  • Submits product labelling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. 
Advisory Responsibilities
  • Participates in global teams and provides regulatory strategy and guidance to global product development teams.
  • Under minimal supervision develops US, Canada, and EU regulatory filing strategy.
  • Provides regulatory strategy and guidance to global product owner/project team.
  • Makes recommendations to shape the global strategy in line with regional/commercial objectives
    Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
  • Works collaboratively with cross-functional team to resolve complex project issues.
  • Has recognized regulatory expertise and extensive knowledge of regulatory requirements with ability to strategically interpret and communicate requirements.
  • Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
  • Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration. 
Communications and Business Support
  • Represents department on global project teams.
  • Maintains professional relationships within the regulatory groups and with functional areas outside regulatory
  • Develops professional relationships with Health Authorities, when required.
  • Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others.
  • Conveys information on team timelines and status to supervisor.
  • Delivers presentations within the Company, as required.
  • Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities. 
Mentoring Responsibilities
  • Performs peer review of complex regulatory documents.
  • Provides leadership and development support to the Regulatory team.
  • As appropriate, supervises and ensures training and development for Regulatory staff to ensure execution of all duties in a timely and efficient manner.
  • Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations. 
Process and Organizational Effectiveness
  • Provides input into development of processes to leverage Client global processes and infrastructure and maximize efficiency and effectiveness.
  • Provide input into critical metrics and management reports
  • Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects
  • Maintains a performance and improvement culture
  • Ensure roles and responsibilities for external services within a project are clearly defined and documented
  • Proactively resolve issues related to outsourced activities
  • Updates and maintains appropriate SOPs for the departments. 
Education and Experience
  • Education equivalent to a BS degree in a scientific field, plus 8 years' experience in regulatory affairs; or
  • Education equivalent to a MS degree in a scientific field, plus 6 years' experience in regulatory affairs; or
  • Education equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs
  • Class II medical device experience required, Class III medical device experience preferred.
  • Experience with HCTP and tissue-based medical devices preferred. 
Essential Skills, Experience, and Competencies: (includes Licenses, Credentials)
  • Analytical thinking and problem-solving skill
  • Excellent written and verbal communication skills.
  • Good negotiation skills.
  • Ability to work well independently and with others.
  • Excellent organizational skills and attention to detail.
  • Ability to handle multiple projects simultaneously and maintain flexibility.
  • Experience with Adobe Acrobat, Excel, Power Point, and Word, and ability to learn new computer programs.
  • Ability to understand and use technical documents, such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.
  • Critical thinking skills and ability to follow-through.
  • In-depth knowledge of US medical device regulations as well as significant knowledge of Canadian and EU regulations.
  • Ability to demonstrate leadership in job performance by example.
  • Ability to function in a regulated environment and handle confidential data.
  • Ability to lead and motivate others.
  • Ability to meet deadlines; take initiative and make decisions within department/company guidelines. 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com