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Regulatory Affairs Specialist (Level II) Job

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Date: Jul 15, 2021

Location: Benito Juárez, DF, DIF, MX

Company: Boston Scientific

Additional Locations: Mexico-DF-Benito Juárez

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Purpose

 

  • Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrationsn++ preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.

 

Responsibilities

 

  • Provides input on regulatory-related issues associated with compliance and achieving the business plan.
  • Prioritize and plan on product registration for his/her respective product lines.
  • Preparing, coordinating and submitting regulatory applications to the local health authority.
  • Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration.
  • Ensure product registrations are reviewed and renewed as required.
  • Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
  • Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
  • Supports tender operations by timely supply of accurate regulatory documents.
  • Supports tender operations by timely supply of accurate regulatory documents.
  • Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
  • Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
  • Serves as regulatory consultant to marketing team and government regulatory agencies.
  • Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.

 

Management Requirements

 

  • Not applicable.

 

Job Scope and Leveling Guidelines

 

  • Knowledge: A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
  • Problem Solving: Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.
  • Planning and Organization: Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Discretion/Latitude; Supervision Received; Decision Making: Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.
  • Business Relationships and Project Management: Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

 

What We’re Looking For:

  • Career: Pharmaceutical, Chemical, Biotechnology, Biomedical or related.
  • At least 5 years of experience executing regulatory affairs activities in any health-related (Medical devices preferred) company
  • Execution and Initiative driven individual, highly analytical
  • Knowledge about the local regulations (policies )  in health and the medical device industry (NOM 241, NOM 240, NOM 137) also the general  knowledge about international regulations organism  as FDA, Health Canada and EU MDR  will be appreciated.
  • Coordinate regulatory documentation activities and maintain data in information systems or databases.
  • Direct contact with the Global RA specialist to get the legal documentation required for new products.
  • Provide technical information of the products  as COAs, DHR, CFGs, ISO certificates, etc.. requested by customers or by the tender’s teams.
  • Create and execute timely manner the Work Plan for submissions, renewals, and amendments of the regulatory projects and ensure full compliance with regulations of the products in charge.
  • Evaluate applicable laws and regulations to determine impact on company activities.
  • Identify and interpret relevant regulatory guidelines
  • Perform the assessment for the country related to any change notice communicated
  • Provide guideline and constant information to the commercial team about the best strategies to new product launches.
  • Strong communication skills.
  • Ability to think strategically and innovatively
  • Learning agility and emotional intelligence to adapt and respect cultural differences.
  • Proven leadership skills to motivate and influence teams that do not report directly into the role
  • High proficiency of English language B2 level.

Requisition ID: 483784

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


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