Senior Regulatory Affairs Specialist

Created by: Abbott
Added: 16.03.2020

Advert description

Responsibilities
  • Manage the regulatory approval or registration of medical devices and license maintenance
  • Develop registration strategies, prioritizing assignments, implementing the regulatory plan and coordinating multiple projects and activities in accordance with strategic company objectives, annual plan, and LRP targets.
  • Research regulatory requirements for assigned geographies, if required
  • Monitor emerging trends and integrate new requirements into registration and approval strategies
  • Monitor and disseminate information on changes to local, regional and global medical device laws & regulations affecting registration, manufacture, distribution and sale & marketing of Abbott products
  • Review, analyze and co-ordinate data for new product submissions, line extensions, variations to marketed products according to priority. Monitor the progress of marketing applications and provide management with a monthly registration status report.
  • Cultivation of professional working relationships with local regulatory authorities and local medical device industry association
  • Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain; and
  • Liaising with external parties on matters relating to the Malaysian medical device regulatory requirements.
  • Serve as an internal consultant on regulatory issues such as recalls, advertising, and promotional activities, field actions or review of proposed device changes
  • Review and approval of A&P materials to ensure compliance with local regulations.
  • Also responsible for a variety of quality and compliance activities including but not limited to post-market surveillance, adverse events reporting, field action reporting etc.
QUALIFICATIONS: Describe the minimum education and experience, including knowledge, skills, and abilities, required to successfully perform the job. List any certificates and/or registration required.
  • Bachelor's degree in relevant major.
  • Experience gained in multinational companies, especially in Medical devices and/or drugs is a plus.

Other Functions And Responsibilities
  • Execute the job responsibilities according to applicable standard operating procedures of SJM Asia and SJM Malaysia
  • Perform other related functions and responsibilities assigned by the supervisor
  • Serve as back up in the absence of other team members

Performance Factors
  • Focuses on the Customer: Is dedicated to meeting the needs of internal and external customers
  • Delivers Results with Integrity: Meets commitments and produces the right results at the right time. Adheres to moral and ethical principles. Believable and trustworthy. Does what he/she says they are going to do
  • Teamwork/Supporting our Colleagues: Collaborates with co-workers to achieve workgroup and company goals
  • Initiative: Takes action without prompting or direction from others. Constantly strives to improve own and company performance
  • Personal Involvement: Personally engages his/her interests, emotions or commitments in their work

Specific details

Type of Contract Full time
Preferred Education Bachelor's
Level of Experience 2-5 years

Location

Malaysia, Asia
Petaling Jaya